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PMA Final Decisions for May 2010

Posted Jul 07 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 APPROVAL
DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P050027
5/28/10
Karl Storz Photodynamic Diagnostic D-Light C (PDD) System Karl Storz Endoscopy-America, Inc.
El Segundo, CA
90245
Approval for the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System. The Karl Storz Photodynamic Diagnostic D-Light C (PDD) System in combination with the optical imaging drug Cysview® (hexaminolevulinate hydrochloride) for Intravesical Solution is indicated for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive papillary cancer of the bladder in patients suspected or known to have the lesion on the basis of a prior cystoscopy.
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P810031/S037
5/20/10
Real-Time
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon®, Healon GV® and Healon5® Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Approval for a change in packaging for two individual blister tray packs (Healon® & Healon5®) to be packed in a single carton box.
P820003/S093
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P850051/S072
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P850079/S047
5/3/10
180-Day
CLEAR SOFT (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear CooperVision
Norfolk, VA
23507
Approval for the trade name CLEAR SOFT. The device, as modified, will be
marketed under the trade name CLEAR SOFT and is indicated for:
CLEAR SOFT Sphere (methafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by
persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
CLEAR SOFT Toric (methafilcon A) Soft Contact lenses are indicated for the correction
of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons
with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic
corrections from
-0.25 to -5.00 diopters.
The CLEAR SOFT (methafilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights/7 days of continuous wear. It is
recommended that the contact lens wearer first be evaluated on a daily wear schedule. If
successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.
Eye care practitioners may prescribe the lens for frequent replacement wear with cleaning, disinfecting and scheduled replacements.
P860019/S252
5/11/10
Real-Time
Quantum Maverick OTW, Apex OTW, Maverick OTW, and Maverick XL Monorail PTCA Dilatation Catheters Boston Scientific Corporation
Maple Grove, MN
55311
Approval for material and specification changes to the strain relief.
P890003/S186
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P890003/S188
5/11/10
Real-Time
Medtronic® CareLink Device Data Management Application (DDMA) Model 2491 Medtronic, Inc.
Mounds View, MN
55112
Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events.
P900061/S087
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P910023/S226
5/7/10
180-Day
Fortify VR/DR St. Jude Medical Cardiac Rhythm Management Division
Sunnyvale, CA
94086
Approval for the Fortify VR/DR pulse generators.
P910077/S104
5/19/10
Real-Time
Zoom Latitude Programmer Boston Scientific CRM
St. Paul, MN
55112
Approval for a minor design change to the Model 3120 Zoom Latitude programmer and an alternate supplier for the hard drive component in the programmer.
P930022/S011
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P950037/S072
5/7/10
180-Day
Evia/Entovis Pulse Generators Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Evia/Entovis Pulse Generators.
P960013/S058
5/19/10
Real-Time
OptiSense St. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Approval for new stylets to be included in the OptiSense Model 1999 lead package.
P970003/S109
5/18/10
Special
VNS Therapy System Cyberonics, Inc.
Houston, TX
77058
Approval for a labeling modification regarding the internal clock reset in the Model 100, 101, 102 and 102R Implanted pulse Generators (IPGs).
P970008/S049
5/13/10
Real-Time
Urologix Targis® System Urologix, Inc.
Minneapolis, MN
55447
Approval to replace an obsolete touchscreen and modify the microwave generator to improve design margins.
P970012/S065
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P970021/S028
5/13/10
180-Day
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc.
Somerville, NJ
08876
Approval for updated professional labeling to reflect the results of the Post-Approval Study required as a condition of approval to Supplement 14.
P970051/S057
5/14/10
135-Day
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO
80111
Approval for a change to the material used in the manufacturing of the microphone protector cover for the CP810 Sound Processor.
P980016/S232
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P980016/S234
5/11/10
Real-Time
Medtronic® Secura® DR/VR D224DRG/ D224VRC, Maximo® DR/VR D284DRG/ D284VRC, Virtuoso II DR/VR D274DRG/ D274VRC Implantable Cardioverter Defibrillators Medtronic, Inc.
Mounds View, MN
55112
Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events.
P980035/S161
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P980050/S047
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P990001/S064
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P990020/S039
5/21/10
180-Day
ANEURx AAAdvantage Stent Graft Delivery System Medtronic Vascular
Santa Rosa, CA
95403
Approval for a sterilization site located at Isotron Ireland, LTD., in Offaly, Ireland.
P990027/S010
5/18/10
180-Day
Bausch & Lomb Technolas T217z Zyoptix Laser System Biomed Research, Inc.
Lutz, FL
33558
Approval for the following changes: 1) Removal of a redundant fluence test;
2) Introduction of a new scanner system from GSI to the laser System:
3) Extrapolation of the Wavefront data in the Diagnostic Zywave Software;
4) New ZRS (Zyoptix Remote Support) Software to monitor the performance of the
laser and diagnostic devices remotely via the internet;
5) Modification of the ZRS to include TruLink, an enhancement to the ZRS system;
6) Introduction of a new OP field illumination in the laser system;
7) Change of the video chip in the CCD Lenslet Camera DMK4002-IR; and
8) Change in the supplier of the temperature control unit in the laser system.
P990038/S013
5/21/10
135-Day
ETI-MAK-2 PLUS & ETI-MAK-2 PLUS HBsAg Confirmatory Test DiaSorin, Inc.
Stillwater, MN
55082
Approval for changing BSA raw material.
P990041/S012
5/21/10
135-Day
ETI-AB-EBK PLUS DiaSorin, Inc.
Stillwater, MN
55082
Approval for changing BSA raw material.
P990042/S009
5/21/10
135-Day
ETI-AB-AUK PLUS DiaSorin, Inc.
Stillwater, MN
55082
Approval for changing BSA raw material.
P990043/S013
5/21/10
135-Day
ETI-EBK PLUS DiaSorin, Inc.
Stillwater, MN
55082
Approval for changing BSA raw material.
P990044/S010
5/21/10
135-Day
ETI-CORE-IGMK PLUS DiaSorin, Inc.
Stillwater, MN
55082
Approval for changing BSA raw material.
P990045/S010
5/21/10
135-Day
ETI-AB-COREK PLUS DiaSorin, Inc.
Stillwater, MN
55082
Approval for changing BSA raw material.
P990066/S035
5/20/10
180-Day
GE-Healthcare Senographe Essential Digital Mammography System GE Healthcare
Milwaukee, WI
53201
Approval for a modification to the amorphous silicon array design used in the detector of the Senographe Essential full field digital mammography system. The proposed modifications include the following:
1) Reducing the number of layers in the detector amorphous silicon array; 2) Change in the detector firmware to allow the detector configuration to be communicated to the system Image Detector Controller (IDC); 3) IDC software to automatically determine if a detector with the proposed modification is installed on the system and properly select the proper configuration table; and
4) Corresponding changes in the incoming acceptance criteria testing station for the modified detector.
P000009/S035
5/7/10
180-Day
Evia/Entovis Pulse Generators Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Evia/Entovis Pulse Generators.
P000021/S013
5/19/10
180-Day
Dimension Vista® TPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Approval for the following changes:
1) Detection technology from spectrophotometry to chemiluminesence;
2) Appropriate reagent process changes to accommodate chemiluminesence detection;
3) Usage on the Dimension Vista® 1500 System;
4) Usage on the Dimension Vista® 3000T System which consists of two Dimension Vista®
1500 Systems connected by a sample track transport mechanism;
5) Usage on the Dimension Vista® 1500 System connected to the StreamLab® analytical
Workcell Laboratory Automation System; and
6) The new Dimension Vista® PSA Calibrator for use with the Dimension Vista® TPSA and FPSA methods.
The device, as modified, will be marketed under the trade name Dimension Vista® TPSA Flex
reagent cartridge and is indicated for the following uses:
The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate
specific antigen (PSA) in human serum and plasma on the Dimension Vista® System:
1) As an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer. 2) As an aid in the
management (monitoring) of prostate cancer patients.
The Dimension Vista PSA calibrator will be marketed separately for use with the Dimension
Vista TPSA Flex reagent and is indicated for the calibration of Total (TPSA) and Free (FPSA) Prostate Specific Antigen methods on the Dimension Vista® Systems.
P000021/S015
5/27/10
180-Day
Dimension TPSA Flex Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Approval for the Dimension TPSA Flex reagent cartridge on the Dimension EXL with LM System.
P000054/S024
5/17/10
Special
INFUSE® Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for changes to the patient information brochure.
P000058/S036
5/17/10
Special
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device Medtronic Sofamor Danek
Memphis, TN
38132
Approval for changes to the patient information brochure.
P010003/S015
5/12/10
Special
BioBlue® Surgical Adhesive CryoLife, Inc.
Kennesaw, GA
30144
Approval for clarification regarding one of the warnings in the Instructions for Use (IFU).
P010015/S082
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P010030/S019
5/21/10
Real-Time
LifeVest Wearable Defibrillator WCD 4000 Zoll Lifecor Corporation
Pittsburgh, PA
15238
Approval for a component value change to the ECG electrode buffer boards to improve ECG amplifier common mode rejection.
P010031/S191
5/11/10
Real-Time
Various Device Families Medtronic, Inc.
Mounds View, MN
55112
Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P010031/S193
5/11/10
Real-Time
Medtronic® Consulta CRT-D D224TRK, Maximo® II CRT-D D284TRK, Concerto™ II D274TRK Implantable Cardioverter Defibrillators with Cardiac Resynchronization Medtronic, Inc.
Mounds View, MN
55112
Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events.
P020004/S049
5/5/10
135-Day
GORE EXCLUDER® AAA Endoprosthesis W.L. Gore and Associates
Flagstaff, AZ
86001
Approval for an expansion of the manufacturing environment.
P020004/S050
5/12/10
Real-Time
GORE EXCLUDER® AAA Endoprosthesis W.L. Gore and Associates
Flagstaff, AZ
86001
Approval for the removal of the center knot sleeve attachment.
P020009/S061
5/11/10
Real-Time
Express OTW Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for material and specification changes to the strain relief.
P020027/S009
5/17/10
180-Day
Dimension Vista® FPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Approval for the following changes:
1) Detection technology from spectrophotometry to chemiluminesence;
2) Appropriate reagent process changes to accommodate chemiluminesence detection;
3) Usage on the Dimension Vista® 1500 System;
4) Usage on the Dimension Vista® 3000T System which consists of two Dimension Vista®
1500 Systems connected by a sample track transport mechanism; and
5) Usage on the Dimension Vista® 1500 System connected to the StreamLab® analytical
Workcell Laboratory Automation System.
The device, as modified, will be marketed under the trade name Dimension Vista® FPSA Flex
reagent cartridge and is indicated for:
The FPSA method for the Dimension Vista® System is an in vitro diagnostic test intended to quantitatively measure free prostate
specific antigen (FPSA) in human serum and plasma. Measurements of FPSA are used in conjunction with total PSA (TPSA) method on Dimension Vista® System to calculate FPSA to TPSA ratio expressed as a percent FPSA. The percent FPSA is used as an aid in distinguishing prostate cancer from benign prostate conditions in men 50 years or older with TPSA of 4.0 to 1.0 ng/mL and DRE findings not suspicious for cancer. Prostate biopsy is required for diagnosis of cancer.
P020027/S010
5/27/10
180-Day
Dimension FPSA Flex Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Approval for the Dimension FPSA Flex reagent cartridge on the Dimension EXL with LM System.
P030017/S098
5/6/10
Real-Time
Precision® Spinal Cord Stimulation (SCS) System Boston Scientific Neuromodulation Corp.
Valencia, CA
91355
Approval for a consolidation of three separate instruction manuals (i.e., Physician Implant, Physician Lead, and Physician Surgical Lead Manuals) into a single manual, the Physician System Clinical manual.
P030025/S085
5/11/10
Real-Time
Taxus Express2 Coronary Stent System, Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for material and specification changes to the strain relief.
P030054/S130
5/10/10
180-Day
QuickFlex µ Left Ventricular Lead St. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342
Approval for the QuickFlex µ Model 1258TLeft Ventricular Lead.
P030054/S141
5/7/10
180-Day
Unify CRT-D St. Jude Medical Cardiac Rhythm Management Division
Sunnyvale, CA
94086
Approval for the Unify CRT-D pulse generators.
P030054/S146
5/3/10
180-Day
Merlin Patient Care System Programmer Model 3650 St. Jude Medical Cardiac Rhythm Management Division
Sunnyvale, CA
94086
Approval for: 1) The addition of the pacing systems analyzer (PSA) model EX3100. The model EX3100 also includes accessories:
a) Merlin Antenna Adapter EX3190;
b) Merlin Cable Adapter EX3170; and c) Merlin “M” Adapter EX3180; and 2) The addition of the Model 3330 version 10.1.1 software.
P040002/S027
5/12/10
Real-Time
PowerLink System Endologix, Inc.
Irvine, CA
92618
Approval for new PowerLink system models, including bifurcated devices with new lengths and diameters, limb extensions with new lengths, and aortic extensions with new lengths.
P040016/S054
5/11/10
Real-Time
VeriFLEX OTW Bare-Metal Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for material and specification changes to the strain relief.
P040034/S016
5/28/10
180-Day
DuraSeal® Dural Sealant System Confluent Surgical, Inc.
Bedford, MA
01730
Approval to update the contents of the DuraSeal Package Insert based on the results of the post-approval study.
P040043/S033
5/25/10
Real-Time
GORE TAG Thoracic Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval for a new 22 mm constraining sleeve size to be used in the 40 mm diameter TAG device.
P050023/S024
5/7/10
180-Day
Evia/Entovis Pulse Generators Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Evia/Entovis Pulse Generators.
P050033/S008
5/24/10
Special
Elevess Anika Therapeutics, Inc.
Bedford, MA
01730
Approval for revision of the physician and patient labels to include updates on the post market adverse event experience with the device.
P060002/S006
5/18/10
180-Day
Flair Endovascular Stent Graft C.R. Bard
Tempe, AZ
85281
Approval of the post-approval protocol.
P060006/S006
5/28/10
180-Day
Express™ SD Renal Monorail™ Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for reinstatement of a secondary sterilization site formerly owned by Steris Isomedix Services, Inc. (Steris) located in Coventry, Rhode Island.
P060006/S010
5/11/10
Real-Time
Express™ SD Renal Monorail™ Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for material and specification changes to the strain relief.
P060008/S045
5/11/10
Real-Time
TAXUS® Liberté® OTW Paclitaxel-Eluting Coronary Stent System, Taxus Liberte Atom OTW Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for material and specification changes to the strain relief.
P060008/S047
5/17/10
Real-Time
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for MR compatibility labeling changes to the Directions for Use (DFU) and Patient Information Guide (PG) for the TAXUS Liberté Monorail (MR) and Over-the-Wire (OTW) Stent Delivery Systems.
P060040/S010
5/7/10
180-Day
Heartmate II Left Ventricular Assist System Thoratec Corporation
Pleasanton, CA
94588
Approval of the post-approval study protocol.
P070008/S011
5/7/10
180-Day
Evia/Entovis Pulse Generators Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Evia/Entovis Pulse Generators.
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P790007/S025
5/28/10
Hancock® I Low Porosity and Modified Orifice Valved Conduit Medtronic, Inc.
Santa Ana, CA
92705
Addition of Gorditos Meats as an alternate supplier.
P810046/S238
5/13/10
Voyager® NC Coronary Dilatation Catheter Abbott Vascular, Inc.
Temecula, CA
92591
Change in the extrusion process for the tubing used to manufacture the Voyager® NC Coronary Dilatation Catheter’s 3.50 mm through 5.00 mm balloons.
P830061/S051
5/19/10
CapSure Sense, Vitatron Medtronic, Inc.
Mounds View, MN
55112
Addition of a second source supplier of electrode components.
P840001/S152
5/20/10
Restore Implantable Stimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of the supplemental Automated Optical Inspection (AOI).
P840001/S153
5/27/10
RestoreULTRA Implantable Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Change to qualify a connector rework process for the device manufacturing processes at Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico.
P860004/S127
5/20/10
Personal Therapy Manager Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of the supplemental Automated Optical Inspection (AOI).
P860019/S255
5/2710
Apex™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter Boston Scientific
Maple Grove, MN
55311
Alternate sterilization cycle to be used at Isotron, Tullamore, Ireland.
P870078/S009
5/28/10
Hancock® Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705
Addition of Gorditos Meats as an alternate supplier.
P890003/S190
5/14/10
Carelink Programmer Medtronic, Inc.
Mounds View, MN
55112
Change to the antenna support, manufacturing process changes related to the antenna support change, and changes to an antenna test.
P890064/S022
5/17/10
 digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test Qiagen Gaithersburg, Inc.
Gaithersburg, MD
20878
Change in supplier for the reagent in the device.
P890064/S023
5/17/10
 digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test Qiagen Gaithersburg, Inc.
Gaithersburg, MD
20878
Enabling the existing barcode reader configuration within the equipment software during the production of the device.
P890064/S024
5/17/10
 digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test Qiagen Gaithersburg, Inc.
Gaithersburg, MD
20878
Scale-up in the production of a component in the device.
P910073/S083
5/21/10
Reliance Family of Leads Boston Scientific Corporation
St. Paul, MN
55112
Replacement of existing automated measuring equipment.
P930039/S037
5/19/10
CapSureFix Novus, Vitatron Medtronic, Inc.
Mounds View, MN
55112
Addition of a second source supplier of electrode components.
P940031/S067
5/20/10
Discovery SR and DR Boston Scientific Corporation
St. Paul, MN
55112
 
Elimination of the outer sleeve wash step.
P950029/S052
5/26/10
Symphony, Rhapsody, Reply, Reply (V2), and Esprit Family of Pacemakers ELA Medical, Inc.
Plymouth, MN
55441
Change in location of the hybrid electronic module subcomponent manufacturing.
P950037/S080
5/13/10
Sterox S and Dextrus Family of Implantable Pacemaker Pulse Generators and Programmers Biotronik, Inc.
Lake Oswego, OR
97035
Change in packaging to the inner and outer bags of the sterilized stylet accessories.
P960009/S082
5/20/10
Activa Family of Implantable Stimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of the supplemental Automated Optical Inspection (AOI).
P960013/S059
5/13/10
Tendril, Tendril ST, Tendril STS, and Optisense Leads St. Jude Medical
Sylmar, CA
91342
Change in MCRD manufacturing process.
P960030/S030
5/13/10
Passive Plus, Isoflex S & P, and Isoflex Optim Leads St. Jude Medical
Sylmar, CA
91342
Change in MCRD manufacturing process.
P960040/S221
5/19/10
Confient and Vitality HE Families of Pulse Generators Boston Scientific Corporation
Cardiac Rhythm Management
St. Paul, MN
55112
Plating change to the reed switch component.
P960040/S222
5/19/10
Ventak Prizm, Ventak Prizm 2, Vitality,
Vitality HE,
Vitality 2,
Vitality AVT, and Confient Families of ICDs
Boston Scientific Corporation
Cardiac Rhythm Management
St. Paul, MN
55112
 
Multiple cleaning and component testing changes for the crystal oscillator component.
P960040/S223
5/20/10
Confient and Vitality Families of ICDs Boston Scientific Corporation
Cardiac Rhythm Management
St. Paul, MN
55112
 
Changes in the suppliers for thin-film resistors.
P960043/S071
5/5/10
Perclose® AT 6F and Perclose® ProGlide™ Suture Medicated Closure Systems Abbott Vascular, Inc.
Redwood City, CA
94063
Addition of an alternate supplier for two overmolded components.
D970003/S118
5/19/10
Altrua Family of IPGs Boston Scientific Corporation
St. Paul, MN
55112
Changes for hybrid assembly transfer, a new laser marking tool, an automated solder ball shear inspection test, and the removal of a pre-screening inspection.
D970003/S119
5/20/10
Nexus I Entra SSIR, Nexus I Entra SSI, Nexus I Entra DDD, Nexus I Entra DDDR, Nexus I Plus DDDR, Discovery II SR, Insignia I Entra SSI, Insignia I Entra DDD, Insignia I Entra DDDR, Insignia I Entra SSIR, Insignia I Ultra DDDR, Insignia I Plus DDDR, Intelis II DR, and Intelis II SR Boston Scientific Corporation
St. Paul, MN
55112
 
Elimination of the outer sleeve wash step.
P970004/S085
5/20/10
Interstim iCOn Patient Programmer Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of the supplemental Automated Optical Inspection (AOI).
P970027/S008
5/13/10
AxSYM Anti-HCV Abbott Laboratories Diagnostic Division
Abbott Park North, IL
60064
Change to the efficacy testing performed on new incoming lots of conjugate concentrate for the device.
P970031/S029
5/28/10
Freestyle® Aortic Root Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705
Addition of Gorditos Meats as an alternate supplier.
P980016/S236
5/12/10
EnTrust ICD, Virtuoso ICD, Intrinsic, Marquis, Maximo,
Maximo II DR/VR, Virtuoso II DR/VR, Secura DR ICD, Secura VR ICD
Medtronic, Inc.
Mounds View, MN
55112
Additional supplier for the plating process.
P980023/S040
5/13/10
Linox SD and Linox S Family of ICD Pacing Leads Biotronik, Inc.
Lake Oswego, OR
97035
Change in packaging to the inner and outer bags of the sterilized stylet accessories.
P980035/S165
5/12/10
EnRhythm IPG Medtronic, Inc.
Mounds View, MN
55112
Additional supplier for the plating process.
P980040/S033
5/20/10
TECNIS® Multifocal One-Piece Intraocular Lens Advanced Medical Optics, Inc.
Santa Ana, CA
92705
Change in the sterilization cycle parameters for the device.
P980043/S025
5/13/10
Hancock® II Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705
Change to the valve holder assembly process and inspection documents.
P980043/S026
5/28/10
Hancock® II Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705
Addition of Gorditos Meats as an alternate supplier.
P980049/S056
5/26/10
Paradym Family of ICDs ELA Medical, Inc.
Plymouth, MN
55441
Change in location of the hybrid electronic module subcomponent manufacturing.
P990001/S066
5/12/10
DA+ C-Series,
DA+ T-Series
Medtronic, Inc.
Mounds View, MN
55112
Additional supplier for the plating process.
P990037/S030
5/7/10
Vascular Solutions Duett Sealing Device Vascular Solutions
Minneapolis, MN
55369
Change in the quality control device used to monitor the sterilization process from an in-house manufactured sterilization process control device (SPCD) to a commercially purchased PCD.
P990064/S032
5/13/10
Mosaic® Porcine Bioprosthesis Medtronic, Inc.
Sana Ana, CA
92705
Change to the valve holder assembly process and inspection documents.
P990064/S033
5/28/10
Mosaic® Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705
Addition of Gorditos Meats as an alternate supplier.
P990066/S036
5/27/10
Senographe Digital Mammography System GE Healthcare
Waukesha, WI
53188
Change in supplier and replacement of obsolete computer systems.
P000006/S019
5/6/10
Titan Inflatable Penile Prosthesis Coloplast Corp.
Minneapolis, MN
55411
Use of an automated piece of equipment in dipping large size Titan cylinders.
P000039/S036
5/28/10
Amplatzer® Septal Occluder AGA Medical Corporation
Plymouth, MN
55442
Change in the supplier of the stitching yarn used in select Nitinol occlusion devices.
P010012/S234
5/20/10
Cognis,
Contak Renewal, Contak Renewal 3 RF, Contak Renewal 3 HE,
Contak Renewal 3 RF HE, Contak Renewal 3, Contak Renewal 3 AVT
HE, Contak Renewal 4 AVT, Contak Renewal 4 AVT HE, Livian LV1
SE, and Livian LV1 HE
Boston Scientific Corporation
St. Paul, MN
55112
 
Elimination of the outer sleeve wash step.
P010012/S240
5/19/10
Livian, Renewal 3, Renewal 3RF, and Renewal 3 AVT Families of Pulse Generators Boston Scientific Corporation
Cardiac Rhythm Management
St. Paul, MN
55112
Plating change to the reed switch component.
P010012/S241
5/19/10
Contak Renewal, Contak Renewal 3, Contak Renewal 3 HE, Contak Renewal 3 RF, Contak Renewal 3 RF HE, Livian SE, and Livian HE Families of CRT-Ds Boston Scientific Corporation
Cardiac Rhythm Management
St. Paul, MN
55112
 
Multiple cleaning and component testing changes for the crystal oscillator component.
P010012/S242
5/20/10
Contak Renewal 3 and Livian Families of CRT-Ds Boston Scientific Corporation
Cardiac Rhythm Management
St. Paul, MN
55112
 
Changes in the suppliers for thin-film resistors.
P010021/S018
5/20/10
Vitros Immunodiagnostics Products Anti-HCV Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Addition of a new supplier of a raw material used in the manufacture of the Vitro Anti-HCV Calibrator.
P010031/S195
5/12/10
Concerto CRT-D, InSync II Marquis, Consulta CRT-D, InSync II Protect, InSync III Marquis, InSync Marquis, InSync II Protect, Maximo II CRT-D Medtronic, Inc.
Mounds View, MN
55112
Additional supplier for the plating process.
P010047/S003
5/25/10
Neomend ProGel™ Pleural Air Leak Sealant NeoMend, Inc.
Irvine, CA
92618
Modification of a test procedure used to determine the percent protein of human serum albumin in the component manufacturing process and for final release.
P020009/S063
5/13/10
Express 2® Coronary Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Change to the software used during a step in the stent manufacturing process.
P020024/S029
5/28/10
Amplatzer® Duct Occluder AGA Medical Corporation
Plymouth, MN
55442
Change in the supplier of the stitching yarn used in select Nitinol occlusion devices.
P020047/S019
5/21/10
Multi-Link Vision® OTW Coronary Stent System and Multi-Link Mini Vision® OTW Coronary Stent System Abbott Vascular
Temecula, CA
92591
Change to the extrusion manufacturing process.
P030005/S062
5/21/10
Contak Renewal TR Boston Scientific Corporation
St. Paul, MN
55112
 
Change in test limits.
P030005/S063
5/19/10
Contak Renewal TR Family of CRT-Ps Boston Scientific Corporation
Cardiac Rhythm Management
St. Paul, MN
55112
 
Multiple cleaning and component testing changes for the crystal oscillator component.
P030005/S064
5/20/10
Contak Renewal TR Boston Scientific Corporation
St. Paul, MN
55112
 
Elimination of the outer sleeve wash step.
P030009/S041
5/13/10
Driver & Microdriver Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA
95403
Addition of process equipment.
P030025/S088
5/13/10
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Replacement of the final inspection camera with one that performs the existing catheter Final Inspection process at the SDS Final Inspection station.
P030025/S089
5/13/10
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Changes to process software.
P030025/S090
5/13/10
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Change to the software used during a step in the stent manufacturing process.
P030031/S029
5/27/10
Navistar RMT Thermocool Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Addition of second source supplier of the Pebax 40D Tubing.
P040002/S028
5/13/10
Powerlink® Stent Graft with IntuiTrak Delivery System Endologix, Inc.
Irvine, CA
92618
Change to the hemostasis handle assembly of the device.
P040016/S056
5/13/10
VeriFLEX® Coronary Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Change to the software used during a step in the stent manufacturing process.
P040016/S057
5/13/10
VeriFLEX (Liberté®) Coronary Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Change from a manual in-process inspection to an automated in-process inspection.
P040036/S022
5/27/10
Celsius RMT Thermocool Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Addition of second source supplier of the Pebax 40D Tubing.
P040040/S013
5/28/10
Amplatzer® Muscular VSD Occluder AGA Medical Corporation
Plymouth, MN
55442
Change in the supplier of the stitching yarn used in select Nitinol occlusion devices.
P040044/S031
5/4/10
Mynx Vascular Closure Device Access Closure, Inc.
Mountain View, CA
04043
Change to a component joining process.
P050007/S025
5/21/10
StarClose SE® Vascular Closure System Abbott Vascular, Inc
Redwood City, CA
94063
Addition of a post-cure process to the manufacturing of the Release Rod component.
P050010/S005
5/26/10
ProDisc-L Total Disc Replacement Synthes Spine
West Chester, PA
19380
New Mahr perthometer that uses a different software version than the existing Mahr perthometer used to measure surface toughness.
P050010/S006
5/26/10
ProDisc-L Total Disc Replacement Synthes Spine
West Chester, PA
19380
Upgrade of the Rofin Baasel Software, which controls the etching machine, from version 1.0.54 to 1.0.61.
P050023/S030
5/13/10
 
Lumax Family of ICDs and CRT-Ds Biotronik, Inc.
Lake Oswego, OR
97035
Change in packaging to the inner and outer bags of the sterilized stylet accessories.
P060006/S012
5/13/10
Express® SD Renal Monorail® Premounted Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Change to the software used during a step in the stent manufacturing process.
P060008/S049
5/13/10
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Replacement of the final inspection camera with one that performs the existing catheter Final Inspection process at the SDS Final Inspection station.
P060008/S050
5/13/10
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Changes to process software.
P060008/S051
5/13/10
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Change to the software used during a step in the stent manufacturing process.
P060008/S052
5/13/10
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Change from a manual in-process inspection to an automated in-process inspection.
P060022/S007
5/19/10
Akreos® Posterior Chamber Intraocular Lens Bausch & Lomb, Inc.
Aliso Viejo, CA
92656
Elimination of the Ophthalmic Irrigation Solution Specification of the lens storage solution.
P060027/S023
5/26/10
Paradym Family of CRT-Ds ELA Medical, Inc.
Plymouth, MN
55441
Change in location of the hybrid electronic module subcomponent manufacturing.
P070015/S034
5/14/10
XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent Systems Abbott Vascular
Temecula, CA
92591
Change to the balloon manufacturing process.
P070015/S035
5/21/10
Promus™ OTW Everolimus-Eluting Coronary Stent System and Xience V® OTW Everolimus-Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92591
Change to the extrusion manufacturing process.
P090003/S001
5/13/10
Express® LD Iliac Premounted Stent System Boston Scientific Corporation
Cardiovascular
Maple Grove, MN
55311
Change to the software used during a step in the stent manufacturing process.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 65

Summary of PMA Originals Under Review
Total Under Review: 82
Total Active: 34
Total On Hold: 48
Number Greater Than 180 Days: 6

Summary of PMA Supplements Under Review
Total Under Review: 591
Total Active: 386
Total On Hold: 205
Number Greater Than 180 Days: 17

Summary of All PMA Submissions Received
Originals: 3
Supplements: 79

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 65
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 144.7
FDA Time: 91.4 Days MFR Time: 53.3 Days

    
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