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PMA Final Decisions for August 2010

Posted Sep 21 2010 9:00pm

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P080026
8/13/10
Abbott RealTime HBV AssayAbbott Molecular, Inc.
Des Plaines, IL
60018
Approval for the Abbott
RealTime HBV. The device is indicated for:
Abbott RealTime HBV Assay:
Abbott RealTime HBV assay is an in vitro polymerase chain reaction (PCR) assay for use with the Abbott m2000 System DNA reagents and with the Abbott m200sp and m2OOOrt instruments for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) from chronically HBV-infected individuals. The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the Abbott RealTime HBV assay must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance for determining the clinical stage of HBV infection has not been established. Clinical performance characteristics have been established for individuals treated with adefovir dipivoxil. This assay is not intended for use as a screening test in blood or blood products for HBV or as a diagnostic test to confirm the presence of HBV infection. Abbott RealTime HBV Assay Control Kit:
The Abbott RealTime HBV Controls arc used to establish run validity of the Abbott RealTime HBV assay when used for the quantitation of Hepatitis B Virus (HBV) DNA in human serum and plasma (EDTA) from HBV infected individuals.
Abbott RealTime HBV Assay Calibrator Kit:
The Abbott RealTime HBV Calibrators are for calibration of the Abbott RealTime HBV assay when used for the quantitation determination of Hepatitis B Virus (HBV) DNA in human serum and plasma (EDTA) from HBV infected individuals.
APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N18033/S044
8/9/10
135-Day
Vistakon® (etafilcon A) Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Approval for a change in a test method to a finished device contact lens material.
N18033/S045
8/26/10
135-Day
Vistakon® (etafilcon A) Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Approval for a new in-process control point.
P850064/S018
8/20/10
180-Day
Life Pulse High Frequency VentilatorBunnell, Inc.
Salt Lake City, UT
84115
Approval for a modification to the ventilator software.
P860004/S133
8/4/10
135-Day
SynchroMed II Infusion SystemMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for incorporating additional inspections and minor tooling modifications to the pump manufacturing process of the SynchroMed II Infusion System, Model 8637.
P900056/S099
8/13/10
135-Day
Rotablator™ Rotational Angioplasty System (Rotablator System), RotaLink™ Plus, RotaLink Advancer and Exchangeable Catheter (RotaLink Advancer)Boston Scientific Cardiovascular
Maple Grove, MN
55311
Approval for:
1) change from in-house moulding of four components to an outsourced moulding vendor;
2) a change in the moulding gate design and location; 3) change in moulding machine; and
4) change in the inspection process for the components.
P910007/S018
8/31/10
Real-Time
Abbott Architect® Total PSA AssayAbbott Laboratories Diagnostics Division
Abbott Park, IL
60064
Approval for incorporating additional specific performance characteristic information in reference to precision, Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity and measuring interval in the product labeling for the Architect® Total PSA Assay.
P950029/S054
8/18/10
Special
Reply DR/SR and Espirit DR/SR PacemakersELA Medical, Inc.
Plymouth, MN
55441
Approval for adding a reinforced inspection step to the manufacturing process of the device.
P950032/S045
8/17/10
Real-Time
Apligraf (Graftskin)Organogenesis, Inc.
Canton, MA
02021
Approval for revisions to the Diabetic Foot Ulcer and Venous Leg Ulcer Patient Brochures.
P960040/S225
8/6/10
Real-Time
TELIGEN Pulse GeneratorsBoston Scientific Company
St. Paul, MN
55112
Approval for modifications to the front liner component used on the TELIGEN and COGNIS pulse generators in the hybrid assembly and to remove the polyimide tape currently applied over the accelerometer component.
P960058/S084
8/20/10
135-Day
HiResolution Bionic Ear SystemAdvanced Bionics
Sylmar, CA
91342
Approval to modify the final mold process of the Coil-Case/Electrode subassembly to replace manual silicone injection with an automated dispensing mechanism.
P960058/S085
8/24/10
180-Day
Harmony HiResolution Bionic Ear System SoundWave 2.0 Fitting SoftwareAdvanced Bionics
Sylmar, CA
91342
Approval for a new version of fitting software, called SoundWave 2.0.
P970003/S111
8/4/10
180-Day
VNS Therapy SystemCyberonics, Inc.
Houston, TX
77058
Approval of the post-approval study protocol.
P970008/S052
8/27/10
Real-Time
Urologix Targis® SystemUrologix, Inc.
Minneapolis, MN
55447
Approval for:
1) modification of the RFID programming;
2) modification of the coil gap measurement;
3) addition of a cooling system gasket;
4) substitution of a lock screw; and 5) software update to differentiate catheter models, close error messages on restart, and add a preconfigured control unit protocol setting.
P970051/S059
8/20/10
135-Day
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Approval to add an N-Heptane wash of the implant prior to over-molding.
P980007/S010
8/31/10
Real-Time
Abbott Architect® Free PSA AssayAbbott Laboratories Diagnostics Division
Abbott Park, IL
60064
Approval for incorporating additional specific performance characteristic information in reference to precision, Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity and measuring interval in the product labeling for the Architect® Free PSA Assay.
P980022/S080
8/23/10
Real-Time
CareLink™ Pro (MMT-7335)Medtronic, Inc.
Northridge, CA
91325
Approval for a change to the CareLink Pro (MMT-7335)
P980035/S162
8/4/10
Real-Time
Adapta, Sensia, Versa and ReliaMedtronic, Inc.
Mounds View, MN
55112
Approval for manufacturing and design changes to XC177 family of the Ceramic Capacitors.
P980035/S173
8/2/10
Real-Time
Enrhythm IPGMedtronic, Inc.
Mounds View, MN
55112
Approval for the change in Delta 30H Battery Specification.
P990046/S022
8/13/10
Special
ATS Open Pivot Heart Valve and ATS Open Pivot Aortic Valved GraftATS Medical, Inc.
Minneapolis, MN
55447
Approval for labeling changes including changes to the MRI Compatibility information.
P010012/S245
8/6/10
Real-Time
COGNIS Pulse GeneratorsBoston Scientific Company
St. Paul, MN
55112
Approval for modifications to the front liner component used on the TELIGEN and COGNIS pulse generators in the hybrid assembly and to remove the polyimide tape currently applied over the accelerometer component.
P010014/S027
8/31/10
180-Day
Oxford™ Meniscal Unicompartmental Knee SystemBiomet, Inc.
Warsaw, IN
46581
Approval of the post-approval study protocol.
P010015/S092
8/2/10
Real-Time
Delta 30H BatteryMedtronic, Inc.
Mounds View, MN
55112
Approval for the change in Delta 30H Battery Specification.
P020009/S056
8/13/10
135-Day
Express 2® Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for a change to the laser cutting setup process.
P020045/S028
8/6/10
135-Day
Freezor® Cardiac CryoAblation Catheters,
Freezor® Xtra & Freezor® MAX Surgical CryoAblation Devices & CCT.2 CryoConsole System
Applied Physics
Galisteo, NM
87540
Approval for the addition of a new pouch sealer equipment.
P020047/S022
8/31/10
Real-Time
Multi-Link 8™ Small Vessel Coronary Stent System (CSS)Abbott Vascular, Inc.
Temecula, CA
92591
Approval for the 2.25mm diameter stent size as part of the Multi-Link 8 Coronary Stent System. The device, as modified, will be marketed under the trade name Multi-Link 8™ SV Coronary Stent System and is indicated for patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length ≤25 mm) with reference vessel diameters of 2.25mm.
P030025/S078
8/13/10
135-Day
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for a change to the laser cutting setup process.
P030053/S008
8/16/10
180-Day
MemoryGel™ Silicone Gel-Filled Breast ImplantMentor Corporation Santa Barbara, CA
93111
Approval of the post-approval study protocol.
P030054/S158
8/5/10
Real-Time
QuickFlex LeadsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Approval for a modified connector ring on QuickFlex Model 1156T and 1158T left heart leads.
P040003/S008
8/23/10
Real-Time
ExAblateInSightec, Ltd.
Philadelphia, PA
19103
Approval for software changes included in version 4.24 of the work station software.
P040045/S012
8/19/10
135-Day
Vistakon (Senofilcon A) Contact LensVistakon, Division of Johnson & Johnson Vision Care
Jacksonville, FL
32256
Approval for a new in-process control point.
P050023/S034
8/4/10
Real-Time
Lumax 340 and Lumax 540 ICD/CRT-D DevicesBiotronik, Inc.
Lake Oswego, OR
97035
Approval for the Tantalum high voltage capacitors (GB 80413) for Lumax 340 and Lumax 540 ICD/CRT-D devices.
P050027/S001
8/10/10
Real-Time
Karl Storz Photodynamic D-Light C (PDD) SystemKarl Storz Endoscopy-America, Inc.
El Segundo, CA
90245
Approval for:
1) replacement of the existing Karl Storz Camera Control Unit (CCU), trade name “Tricam SL,” with a new model to be marketed under the trade name “Tricam SL II”; and 2) minor labeling changes to reflect the change in the CCU trade name.
P050033/S009
8/25/10
Special
HydrelleAnika Therapeutics, Inc.
Bedford, MA
01730
Approval for a quality control test method change for protein content determination of Sodium Hyaluronate ( NaHA) Powder.
P060006/S004
8/13/10
135-Day
Express® SD Renal Monorail® Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for a change to the laser cutting setup process.
P060034/S004
8/2/10
180-Day
MONOLISA™ Anti-HBc IgM EIA on the Evolis™ Automated Microplate SystemBio-Rad Laboratories
Redmond, WA
98052
Approval for expanding the intended use to include use with the Evolis™
Automated Microplate System. The device, as modified, will be marketed under the trade name
MONOLISA™ Anti-HBc IgM EIA and is indicated for use in the qualitative detection of IgM
antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma (potassium
EDTA, sodium citrate, ACD [acid citrate dextrose], lithium heparin and sodium heparin). Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. The MONOLISA™ Anti-HBc IgM is intended for
manual use and with the Bio-Rad EVOLIS™ Automated Microplate System in the detection of
IgM antibodies to hepatitis B virus.
P070009/S007
8/10/10
135-Day
REALIZE™ Adjustable Gastric Band-C and Injection PortEthicon Endo-Surgery, Inc.
Cincinnati, OH
45242
Approval for converting a manual to an automated pin orienting and feeding assembly process.
P090018/S002
8/16/10
180-Day
Esteem® Totally Implantable Hearing SystemEnvoy Medical Corporation
St. Paul, MN
55110
Approval of the post-approval protocol.
P090018/S003
8/16/10
180-Day
Esteem® Totally Implantable Hearing SystemEnvoy Medical Corporation
St. Paul, MN
55110
Approval of the post-approval protocol.
P090022/S002
8/13/10
Real-Time
Softec HD Posterior Chamber Intraocular Lenses (IOL)Lenstec, Inc.
St. Petersburg, FL 33716
Approval to amend the approved labeling for the Softec HD IOL to allow for the use of the Medicel Viscoject 1.8™, Model# LP604350 with the Softec HD and Softec I IOLs.
APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P820003/S096
8/13/10
Disposable CoverMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P820003/S097
8/13/10
Disposable Cover, External Pulse Generators, Cables, Adapter, Surgical Cable, Patient Safety Cables, Disposable Pouch, SEM PrinterMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P820003/S098
8/18/10
External Pulse GeneratorsMedtronic, Inc.
Mounds View, MN
55112
Changes in the depaneling process for the printed circuit board assemblies.
P820033/S006
8/6/10
Plasmaflo™ OP-05W (A)Asahi Kasei Medical Co. Ltd.
Tokyo, Japan
Addition of a second process equipment set-up for certain process steps in the manufacturing of the finished device and replacement of a mold.
P830061/S053
8/13/10
CapSure SP, CapSure Sense, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence PS+, and Vitatron Excellence+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P830061/S054
8/13/10
CapSure Sense, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence +, and Vitatron Excellence PS+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P830061/S055
8/13/10
CapSure Sense, CapSure SP Novus, Vitatron Crystaline, Vitatron Excellence PS+Medtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P840001/S160
8/27/10
Spinal Cord Stimulation SystemsMedtronic, Inc.
Minneapolis, MN
55432
Changes to the test software used for electrical testing of Medtronic’s implant table neurostimulators.
P850089/S067
8/13/10
CapSure SP Z, CapSure Z Novus, CapSure SP Novus, Vitatron Excellence S+, Vitatron Excellence S++, Vitatron Impulse, and Vitatron Impulse II LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P850089/S068
8/13/10
CapSure Z Novus, CapSure SP Novus, Vitatron Excellence S+, Vitatron Excellence S++, Vitatron Impulse, and Vitatron Impulse II LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P850089/S069
8/13/10
CapSure SP Z Leads, CapSure Z Novus, CapSure SP Novus, Vitatron Excellence SS+, and Vitatron Impulse IIMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P860019/S259
8/13/10
Apex™ Monorail™ and Maverick 2 PTCA CathetersBoston Scientific Corporation
Maple Grove, MN
55311
Change to equipment used for sealing the pouches in which the finished devices are packaged.
P890003/S196
8/13/10
ECG Cable, CapSure VDD, Vitatron Brilliant S+ VDD, Vitatron Legacy, Vitatron Legacy II, and Vitatron Visa LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P890003/S197
8/13/10
Wrench Kit, CapSure VDD, and Vitatron Brilliant S+ VDD LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P890003/S198
8/13/10
CapSure, Brilliant S+ VDD Leads, Prodigy SR, Wrench Kit, Thera-i,
Vitatron Legacy, Vitatron Legacy II, Vitatron Visa, Pacing System
Analyzer, CareLink Monitor, Patient Cable, Analyze Cable, Cables,
Wireless PC card, Xircom Modem, Xircom Combination
Ethernet/Modem Card, ECG Slave Cable, ECG Slave Cable Adaptor, BatteryCheck Monitor, CardioSight Reader, Connector
Port Pin-Plug, Analyzer, Adaptor, Telemetry Programming Head,
Programming Head for 2090, Programming Head for 9790, Patient
Magnet, Programmer, and CareLink Programmer
Medtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P900056/S102
8/26/10
Rotablator™ Rotational Angioplasty System RotaLink™ Plus, RotaLink Exchangeable CatheterBoston Scientific
Maple Grove, MN
55311
Alternate processing materials, and an alternate vendor used to manufacture a component of the Rotablator series of devices.
P900061/S092
8/13/10
Ace Header, Lead End Pin Cap, Upsizing Sleeve, and Transvene Defibrillation LeadMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P900061/S093
8/13/10
Accessory (Upsizing Sleeve) and Lead End Pin CapMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P900061/S094
8/13/10
Accessory (upsizing sleeve), Accessory (upsizing sleeve) for
Unipolar, GEM, PCD Tachy Control System, Jewel, Lead End Pin
Cap, Micro Jewel, Micro Jewel II, Transvene Defibrillation Lead,
External Tachyarrhythmia Control Device (ETCD), Defibrillation
Support.Device (DISD), Patient Magnet, Ace Header, Cables,
Connectors, and Test Load
Medtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P900066/S010
8/18/10
ISPAN Perfluoropropane C3F8 GasAir Liquide Healthcare America Corporation
Plumsteadville, PA
18949
Change of the cleaning solvent used in the perfluoropropane gas manufacturing process.
P910023/S241
8/6/01
Cadence and Current Family of ICDsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Use of alternate cleaning equipment.
P910023/S242
8/6/01
Cadence/Epic/Atlas/Current/Fortify Families of ICDsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Hardware changes to an automated test system used in the capacitor manufacturing process.
P910023/S244
8/13/10
Cadence/Current Families of ICDsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Reduction in receiving inspection sample sizes for components used in the manufacturing of capacitors.
P910023/S245
8/13/10
Cadence, Current, and Fortify Family of ICDsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Use of alternate inspection equipment used in the manufacture of hybrid components.
P910023/S247
8/27/10
Cadence Family of ICDsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Addition of alternate suppliers for a diode component and an organic substrate.
P910073/S085
8/13/10
Endotak Reliance Family of LeadsBoston Scientific CRV
St. Paul, MN
55112
Change in the receiving inspection sampling plan for trilumen silicone tubing.
P910077/S106
8/13/10
Ventak Mini IV ICDBoston Scientific Corporation
St. Paul, MN
55112
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
P920015/S062
8/5/10
Sprint Quattro LeadMedtronic, Inc.
Mounds View, MN
55112
New silicone mold for the shaft seal component.
P920015/S063
8/13/10
Lead Adaptor, Y Adaptor, Tunneling Tool, IS-1 Connector Port Pin Plug Kit, Transvene SVC, Sprint Quattro, Sprint Quattro Secure, Sprint Quattro Single Coil and Subcutaneous Defibrillation LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P920015/S064
8/13/10
IS-1 Connector Port Pin Plug Kit, Transvene SVC, Subcutaneous Defibrillation, Sprint Quattro, Sprint Quattro Secure, and Sprint Quattro Single Coil LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P920015/S065
8/13/10
IS-1 Connector Port Pin Plug Kit, Sprint Quattro, Sprint Quattro Secure, Subcutaneous Lead, Sub-Q Tunneling Tool, Transvene SVC Lead, Lead Adaptor, DF-1 Y Adaptor, Pacer- Cardioverter
Defibrillator
Medtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P920047/S043
8/26/10
Blazer II and Blazer Prime HTD Cardiac Ablation CathetersBoston Scientific Corporation
San Jose, CA
95134
Change in the application of the current shrink tubing process.
P930029/S024
8/13/10
RF Marinr, RF Marinr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, and RF Contactr RF Ablation CathetersMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P930029/S025
8/13/10
RF Marinr, RF Marinr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, and RF ContactrMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P930038/S063
8/27/10
Angio-Seal™ Vascular Closure DeviceSt. Jude Medical
St. Paul, MN
55117
Alternate sterilization inspection method.
P930039/S040
8/13/10
CapSure Fix Novus, SureFix, CapSure Fix, Vitatron Crystalline ActFix, Vitatron Pirouet+, and Vitatron Pirouet S+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P930039/S041
8/13/10
CapSure Fix Novus, SureFix, CapSure Fix, Vitatron Crystalline ActFix, and Vitatron Pirouet S+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P930039/S042
8/13/10
CapSureFix, CapSureFix Novus, SureFix, Vitatron Crystalline ActFix, and Vitatron Pirouet SMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P930039/S043
8/27/10
CapSure Pacing LeadMedtronic, Inc.
Mounds View, MN
55112
Use of a new electrical test fixture.
P940031/S068
8/13/10
Pulsar Max, Meridian, and Discovery PacemakersBoston Scientific Corporation
St. Paul, MN
55112
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
P950021/S012
8/30/10
ADVIA Centaur PSA ImmunoassaySiemens Healthcare Diagnostics
E. Walpole, MA
02032
Implementation of an automated process for making a component that is common to the PSA and cPSA assays.
P950024/S022
8/13/10
CapSure EPI Unipolar and Bipolar LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P950024/S023
8/13/10
CapSure EPI Unipolar and Bipolar LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P950024/S024
8/13/10
CapSure Epicardial Pacing LeadMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P960007/S019
8/25/10
TransCyte Human Fibroblast-Derived Temporary SkinAdvanced BioHealing, Inc.
La Jolla, CA
92037
Eliminating an assay used in the TransCyte manufacturing process.
P960009/S091
8/27/10
Activa Deep Brain Stimulation (DBS)Medtronic, Inc.
Minneapolis, MN
55432
Changes to the test software used for electrical testing of Medtronic’s implant table neurostimulators.
P960016/S030
8/13/10
Livewire TC Cardiac Ablation SystemAtrial Fibrillation Division
Minnetonka, MN
55345
Replacement of the RF Flaring Fixture with a Thermal Flaring Fixture.
P960016/S031
8/13/10
Livewire TC™ Cardiac Ablation SystemS. Jude Medical, Inc.
Minnetonka, MN
55345
Change to the wire-to-ring brazing process.
P960040/S226
8/13/10
Teligen, Confient, Ventak Prizm HE/AT, Ventak Prizm 2, Vitality DS/DS VR/EL, Vitality HE, Vitality AVT, and Vitality 2 ICDsBoston Scientific Corporation
St. Paul, MN
55112
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
D970003/S121
8/13/10
Insignia Ultra/Plus/Entra, Altrua 20/40/60, Pulsar Max II, Meridian II, Discovery II, Intelis II, and Nexus PacemakersBoston Scientific Corporation
St. Paul, MN
55112
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
P970012/S072
8/13/10
Kappa 400 IPGsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P970012/S073
8/13/10
Kappa 400 DR, Kappa 400 SR, and Remote AssistantMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P970012/S074
8/27/10
Kappa 400 DR, Kappa 400 SR IPGsMedtronic, Inc.
Mounds View, MN
55112
Relocation of an ethylene oxide sterilizer.
D970012/S077
8/26/10
AMS Model 700 Inflatable Penile ProsthesisAmerican Medical Systems
Minnetonka, MN
55343
Change to an in-process manufacturing test.
D970012/S078
8/26/10
AMS Model 700 Inflatable Penile ProsthesisAmerican Medical Systems
Minnetonka, MN
55343
Upgrading of certain components used in the INHIBIZONE (IZ) treatment process.
P980016/S253
8/13/10
CapSure Fix Lead, Maximo, Marquis, Intrinsic, EnTrust, and Virtuoso ICDsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P980016/S254
8/13/10
CapSure, Entrust, Gem, Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Secura, Virtuoso, and Virtuoso IIMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P980016/S256
8/20/10
Secura DR/VR, Maximo II DR/VR, Virtuoso II VR/DR, Marquis, Maximo, Intrinsic, Virtuoso, EnTrust ICDsMedtronic, Inc.
Mounds View, MN
55112
Upgrade to the capacitors helium leak test station.
P980016/S257
8/26/10
Virtuoso,
Secura DR/VR, Maximo II DR/VR, and Virtuoso DR/VR ICDs
Medtronic, Inc.
Mounds View, MN
55112
Change in the Laser Ribbon Bonding (LRB) manufacturing process.
P980016/S258
8/27/10
GEM II, Marquis, Maximo, Intrinsic, Entrust, Virtuoso, Maximo II DR/VR, Virtuoso II DR/VR, Secura DR/VR Family of ICDsMedtronic, Inc.
Mounds View, MN
55112
Relocation of an ethylene oxide sterilizer.
P980035/S179
8/13/10
EnPulse, Kappa 700/800/900, Adapta, Sigma, Relia, Sensia, and Versa IPGsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P980035/S180
8/13/10
350 Series, Adapta, AT500, EnPulse, EnRhythm, Kappa 600/500, Kappa 700, Kappa 800, Kappa 900, Relia, Sensia, Versa, Sigma, and Patient ActibatorMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P980035/S181
8/13/10
Adapta/Versa/ Sensia, Relia IPG Family of DevicesMedtronic, Inc.
Mounds View, MN
55112
Addition of an automatic optical inspection (AOI) system.
P980035/S183
8/25/10
EnRhythm IPGsMedtronic, Inc.
Mounds View, MN
55112
Correction to testing procedures at a component supplier.
P980035/S184
8/27/10
Kappa 600/700, 650, 800/900, Relia, Sigma, Medtronic 350, EnPulse, EnRhythm, AT500, Adapta, Versa, and Sensia Family of IPGsMedtronic, Inc.
Mounds View, MN
55112
Relocation of an ethylene oxide sterilizer.
P980035/S185
8/27/10
Adapta/Versa/ Sensia and Relia Families of IPGsMedtronic, Inc.
Mounds View, MN
55112
Optimization of weld process parameters.
P980050/S051
8/13/10
DX-SVC Transvene LeadMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P980050/S052
8/13/10
CS-SVC Transvene LeadMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P980050/S053
8/13/10
Jewel AF, GEM II AT, CS-SVC Transvene Lead and InCheck Patient AssistantMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P990001/S073
8/13/10
DA+ C-Series and DA+ T-SeriesMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P990001/S074
8/25/10
C-Series and T-Series IPGsMedtronic, Inc.
Mounds View, MN
55112
Correction to testing procedures at a component supplier.
P990001/S075
8/27/10
Kappa 400 DR, Kappa 400 SR IPGsMedtronic, Inc.
Mounds View, MN
55112
Relocation of an ethylene oxide sterilizer.
P990013/S026
8/26/10
STAAR Surgical Collamer® Intraocular LensesSTAAR Surgical Company
Monrovia, CA
91016
Relocation of the Glebar Centerless Grinder and Specialty Machine Slicer.
P990013/S028
8/26/10
STAAR Surgical Collamer® Intraocular LensesSTAAR Surgical Company
Monrovia, CA
91016
Change to the aluminum crimp caps used as part of the packaging for the IOLs.
P990055/S013
8/30/10
ADVIA Centaur cPSA ImmunoassaySiemens Healthcare Diagnostics
E. Walpole, MA
02032
Implementation of an automated process for making a component that is common to the PSA and cPSA assays.
P000014/S021
8/19/10
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Additional supplier and an update of the raw material documentation for the supply of human, defibrinated, anti-HBs negative plasma used to manufacture the device.
P000040/S017
8/20/10
Genesys/HTA™ SystemBoston Scientific Corp.
Marlborough, MA
01752
Qualification of a secondary alternative supplier for two components.
P000044/S024
8/30/10
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator; HBsAg Confirmatory KitOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Use of an additional supplier of the material used as mouse monoclonal anti-HBs antibody and update of the raw material of the mouse monoclonal anti-HBs antibody and manufacturing documentation of the VITROS HBsAg Conjugate Reagent.
P000053/S029
8/26/10
AMS 800 Artificial Urinary SphincterAmerican Medical Systems
Minnetonka, MN
55343
Upgrading of certain components used in the INHIBIZONE (IZ) treatment process.
P010012/S246
8/13/10
Cognis, Livian, Contak Renewal, Contak Renewal 3/3 HE, Contak Renewal 3 RF/3RF HE, and Contak Renewal 3 AVT CRT-DsBoston Scientific Corporation
St. Paul, MN
55112
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
P010015/S094
8/13/10
Attain LV, CS and OTW LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P010015/S095
8/13/10
Attain LV and CS LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P010015/S096
8/13/10
Attain InSync, and InSync IIIMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P010015/S098
8/27/10
InSync and InSync III Family of
CRT-Ps
Medtronic, Inc.
Mounds View, MN
55112
Relocation of an ethylene oxide sterilizer.
P010031/S209
8/13/10
InSync Sentry and Maximo ICDsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P010031/S210
8/13/10
Concerto, Concerto II, Consulta, InSync ICD, InSync Marquis, InSync Maximo, InSync II Marquis, Maximo II, InSync II Protect, InSync II Marquis, InSync Sentry, and Conexus ActivatorMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P010031/S212
8/20/10
InSync Sentry ICD, InSync III Marquis ICD, InSync II Marquis ICD, InSync Maximo ICD, Concerto ICD, Consulta CRT-D, Maximo II CRT-D, Concerto II CRT-DMedtronic, Inc.
Mounds View, MN
55112
Upgrade to the capacitors helium leak test station.
P010031/S213
8/26/10
Concerto, Consulta, Maximo II, and Concerto II CRT-DsMedtronic, Inc.
Mounds View, MN
55112
Change in the Laser Ribbon Bonding (LRB) manufacturing process.
P010031/S214
8/27/10
InSync, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync Sentry, InSync Maximo Family of ICDs; Concerto, Concerto II, Maximo II, Consulta Family of CRT-DsMedtronic, Inc.
Mounds View, MN
55112
Relocation of an ethylene oxide sterilizer.
P010047/S004
8/5/10
NeoMend ProGel™ Surgical SealantNeoMend, Inc.
Irvine, CA
92618
Change in the location of the contract manufacturer of one of the components.
P020004/S054
8/6/10
Gore® Excluder® AAA EndoprosthesisW.L. Gore & Associates
Flagstaff, AZ
86002
Addition of a machine for electropolishing nitinol wire.
P020025/S024
8/26/10
Blazer II XP and Blazer Prime XP Cardiac Ablation CathetersBoston Scientific Corporation
San Jose, CA
95134
Change in the application of the current shrink tubing process.
P020026/S080
8/6/10
CYPHER® Sirolimus-Eluting Coronary Stent on RAPTORRAIL® Rapid Exchange Delivery SystemCordis Corporation
Miami Lakes, FL
33014
Change in overage for the spray coating process.
P020036/S018
8/27/10
Smart® Nitinol Stent System and Smart® Control Nitinol Stent SystemCordis Corporation
Miami Lakes, FL
33014
Addition of an in-process inspection.
P030005/S065
8/13/10
Contak Renewal TR CRT-PsBoston Scientific Corporation
St. Paul, MN
55112
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
P030016/S014
8/26/10
STAAR Surgical Implantable Collamer® LensSTAAR Surgical Company
Monrovia, CA
91016
Relocation of the Glebar Centerless Grinder and Specialty Machine Slicer.
P030016/S016
8/26/10
STAAR Surgical Implantable Collamer® LensSTAAR Surgical Company
Monrovia, CA
91016
Change to the aluminum crimp caps used as part of the packaging for the IOLs.
P030036/S019
8/13/10
Anchoring Sleeve Kit and SelectSecure LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P030036/S020
8/13/10
Anchoring Sleeve KitMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P030036/S021
8/13/10
SelectSecure and Anchoring Sleeve KitMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P030047/S021
8/27/10
Precise®, Precise® RX and Precise® PRO Rx Nitinol Stent SystemCordis Corporation
Miami Lakes, FL
33014
Addition of an in-process inspection.
P030054/S160
8/6/01
Epic, Atlas and Promote Family of CRT-DsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Use of alternate cleaning equipment.
P030054/S161
8/6/01
Epic/Atlas/Promote/Unify Families of CRT-DsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Hardware changes to an automated test system used in the capacitor manufacturing process.
P030054/S163
8/13/10
Epic/Atlas/Promote/Unify Families of CRT-DsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Reduction in receiving inspection sample sizes for components used in the manufacturing of capacitors.
P030054/S164
8/13/10
Epic/Atlas/Promote/Unify Families of CRT-DsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Use of alternate inspection equipment used in the manufacture of hybrid components.
P030054/S166
8/27/10
Epic HF/Atlas+ HF Family of CRT-DsSt. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Addition of alternate suppliers for a diode component and an organic substrate.
P040016/S061
8/13/10
VeriFLEX (Liberté) Stent Delivery SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to equipment used for sealing the pouches in which the finished devices are packaged.
P040024/S049
8/12/10
Restylane® Injectable GelMedicis Pharmaceutical Corporation
Scottsdale, AZ
85256
Change in fill volume for Restylane®-L.
P040027/S020
8/6/10
Gore® Viatorr® TIPS EndoprosthesisW.L. Gore & Associates
Flagstaff, AZ
86002
Addition of a machine for electropolishing nitinol wire.
P040037/S027
8/6/10
Gore® Viabahn® EndoprosthesisW.L. Gore & Associates
Flagstaff, AZ
86002
Addition of a machine for electropolishing nitinol wire.
P040043/S035
8/6/10
Gore® TAG® Thoracic EndoprosthesisW.L. Gore & Associates
Flagstaff, AZ
86002
Addition of a machine for electropolishing nitinol wire.
P050006/S017
8/6/10
Gore® Helex Septal OccluderW.L. Gore & Associates
Flagstaff, AZ
86002
Addition of a machine for electropolishing nitinol wire.
P050012/S028
8/25/10
DexCom Seven and Seven Plus Continuous Glucose Monitoring
Systems
DexCom, Inc.
San Diego, CA
92121
Use of a secondary porous pouch sealer for the SEVEN Sensors which are components of the Seven and Seven Plus Continuous Glucose Monitoring Systems.
P050012/S029
8/25/10
DexCom Seven and Seven Plus Continuous Glucose Monitoring
Systems
DexCom, Inc.
San Diego, CA
92121
Change to reduce the hold time after adhesive is applied to attach the adhesive patch to the disposable housing for the Seven and Seven Plus Continuous Glucose Monitoring Systems.
P050012/S032
8/25/10
DexCom Seven and Seven Plus Continuous Glucose Monitoring
Systems
DexCom, Inc.
San Diego, CA
92121
Change to the manufacture of the DexCom Seven and Seven Plus System Receiver to improve the manufacturing consistency of the receiver component of the device.
P050023/S036
8/20/10
Lumax Families of ICDs and CRT-DsBiotronik, Inc.
Lake Oswego, OR
97035
New supplier of a communication component.
P050028/S008
8/30/10
COBAS AmpliPrep/ COBAS TaqMan HBV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Scale-up of a manufacturing process.
P060002/S013
8/13/10
Bard® FLAIR® Endovascular Stent GraftBard Peripheral Vascular, Inc.
Tempe, AZ
85280
Software upgrade and an improvement to the tape wrapping process.
P060002/S014
8/13/10
Bard Flair® Endovascular Stent GraftBard Peripheral Vascular, Inc.
Tempe, AZ
85280
Revised formulation for the adhesive used during manufacturing.
P060030/S012
8/30/10
COBAS AmpliPrep/ COBAS TaqMan HCV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Scale-up of a manufacturing process.
P060039/S014
8/13/10
Attain StarFix LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P060039/S015
8/13/10
Attain StarFix LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.
P070015/S041
8/13/10
XIENCE V® Everolimus-Eluting Coronary Stent System and PROMUS™ Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Inclusion of filter integrity testing to the manufacturing process.
P070015/S042
8/26/10
XIENCE V® Everolimus-Eluting Coronary Stent System and PROMUS™ Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Change to stability testing frequency.
P070015/S043
8/27/10
XIENCE V® Everolimus-Eluting Coronary Stent System and PROMUS™ Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Use of a new final stent crimping machine.
P080006/S011
8/5/10
Attain Ability Family of LeadsMedtronic, Inc.
Mounds View, MN
55112
Transfer of the laser ablation process, the addition of new laser ablation equipment, and changes in the ablation process.
P080006/S012
8/13/10
Attain Ability LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of a new version of traceability software.
P080006/S013
8/13/10
Attain Ability LeadsMedtronic, Inc.
Mounds View, MN
55112
Implementation of an electronic system for incoming inspection data.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 39

Summary of PMA Originals Under Review
Total Under Review: 89
Total Active: 39
Total On Hold: 50
Number Greater Than 180 Days: 5

Summary of PMA Supplements Under Review
Total Under Review: 657
Total Active: 440
Total On Hold: 217
Number Greater Than 180 Days: 18

Summary of All PMA Submissions Received
Originals: 3
Supplements: 64

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 39
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 139.87
FDA Time: 89.85 Days MFR Time: 50.3 Days

    
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