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PMA Final Decisions for April 2010

Posted May 26 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
P080032
4/27/10
Alair Bronchial Thermoplasty System Asthmatx, Inc.
Sunnyvale, CA
94089
Approval for the Alair Bronchial Thermoplasty System. The device is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.
P080029
4/8/10
Quick-Close® Vascular Suturing System Interventional Therapies, LLC
Westport, CT
06880
Approval for the Quick-Close® Vascular Suturing System. This device is indicated as follows:
The Quick-Close® Vascular Suturing System is indicated to close femoral artery access sites and to reduce time-to-hemostasis and time-to-ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5, 6, 7, or 8 French procedural sheath. Additionally, the Quick-Close® Vascular Suturing System is indicated to reduce time-to-hemostasis in patients who have undergone interventional endovascular procedures utilizing a 5, 6, 7, or 8 French procedural sheath, who have received intraprocedural glycoprotein IIb/IIIa inhibitor therapy.
P090007
4/29/10
Elecsys® Anti-HCV Immunoassay
Elecsys® PreciControl Anti-HCV for use on the Cobas e 411 Immunoassay Analyzer
Roche Diagnostics Corporation
Indianapolis, IN
46256
Approval for the Elecsys®
Anti-HCV Immunoassay & Elecsys® PreciControl Anti-HCV Assay for use on cobas e 411 Immunoassay Analyzer. This device is indicated for:
Elecsys® Anti-HCV Immunoassay
The Roche Elecsys Anti-HCV assay is an in vitro diagnostic test for the qualitative detection of total antibodies to hepatitis C virus (anti-HCV) in human serum or plasma (potassium EDTA, lithium heparin and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease. The electrochemilumi-nescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.
Elecsys® PreciControl Anti-HCV
Elecsys PreciControl Anti-HCV is used for quality control of the Elecsys Anti-HCV Immunoassay on the cobas e 411 immunoassay analyzer.
P090008
4/29/10
Elecsys® Anti-HCV Immunoassay
Elecsys® PreciControl Anti-HCV for use on the Cobas e 601 Immunoassay Analyzer
Roche Diagnostics Corporation
Indianapolis, IN
46256
Approval for the Elecsys®
Anti-HCV Immunoassay & Elecsys® PreciControl Anti-HCV Assay for use on cobas e 601 Immunoassay Analyzer. This device is indicated for:
Elecsys® Anti-HCV Immunoassay
The Roche Elecsys Anti-HCV assay is an in vitro diagnostic test for the qualitative
detection of total antibodies to hepatitis C virus (anti-HCV) in human serum or plasma (potassium EDTA, lithium heparin and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease. The electrochemilumi-nescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.
Elecsys® PreciControl Anti-HCV
Elecsys PreciControl Anti-HCV is used for quality control of the Elecsys Anti-HCV Immunoassay on the cobas e 601 immunoassay analyzer.
P090009
4/29/10
Elecsys® Anti-HCV Immunoassay
Elecsys® PreciControl Anti-HCV for use on the MODULAR ANALYTICS E170 Analyzer
Roche Diagnostics Corporation
Indianapolis, IN
46256
Approval for the Elecsys®
Anti-HCV Immunoassay & Elecsys® PreciControl Anti-HCV Assay for use on MODULAR ANALYTICS E170 Analyzer. This device is indicated for:
Elecsys® Anti-HCV Immunoassay
The Roche Elecsys Anti-HCV assay is an in vitro diagnostic test for the qualitative
detection of total antibodies to hepatitis C virus (anti-HCV) in human serum or plasma (potassium EDTA, lithium heparin and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease. The electrochemilumi-nescence immunoassay "ECLIA" is intended for use on the MODULAR ANALYTICS E170 immunoassay analyzer.
Elecsys® PreciControl Anti-HCV
Elecsys PreciControl Anti-HCV is used for quality control of the Elecsys Anti-HCV Immunoassay on the MODULAR ANALYTICS E170 immunoassay analyzer.
P090022
4/12/10
Softec HD Posterior Chamber Intraocular Lens (PCIOL) Lenstec, Inc.
St. Petersburg, FL
33716
Approval for the Softec HD Posterior Chamber Intraocular Lens (PCIOL). The device is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement.
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N18286/S019
4/8/10
Special
Gelfoam Plus Hemostatis Kit Pfizer, Inc.
New York,
New York
10017
Approval to add a statement in the contraindications section of the labeling to address the potential risk in patients with known allergies to porcine collagen.
P860019/S241
4/16/10
Real-Time
NC Quantum Apex Monorail and Over-the-Wire PTCA Catheters Boston Scientific Corporation
Maple Grove, MN
55311
Approval for:
1) a new balloon and markerband materials;
2) extension of the product matrix to include a 6mm length;
3) an alternate bond for Monorail models; and
4) a change in the hydrophilic coating length on Over-the-Wire models.
P870025/S009
4/23/10
135-Day
Fetal Acoustic Stimulator (FAST) GE Healthcare
Laurel, MD
20723
Approval for a change in supplier of a coil assembly.
P900052/S017
4/21/10
Real-Time
PORT-A-CATH II Low Profile Epidural Implantable Access System Smiths Medical MD, Inc.
St. Paul, MN
55112
Approval for modifications to the post-housing material and the guidewire coating.
P910077/S102
4/6/10
Real-Time
Latitude Patient Management System Boston Scientific CRM
St. Paul, MN
55112
Approval for changes to the Latitude Regulated Application Software on Latitude System Server (Model 6488, v6.0).
P940013/S010
4/13/10
180-Day
CIBA VISION® (vasurfilcon A) Soft Contact Lenses CIBA VISION Corporation
Duluth, GA
30097
Approval for a manufacturing site located at P.T. CIBA VISION Batam, Batam Island, Indonesia for Front-end processing of the device.
P950032/S056
4/9/10
Real-Time
Apligraf (Graftskin) Organogenesis, Inc.
Canton, MA
02021
Approval for the introduction of keratinocyte cell strain (HEP072) into the manufacture of Apligraf.
P950037/S078
4/30/10
Real-Time
Lumax 540 VR-T DX Implantable Cardioverter Defibrillator Biotronik, Inc.
Lake Oswego, OR
97035
Approval for introduction of the Lumax 540 VR-T DX Implantable Cardioverter Defibrillator (ICD), a single lead ICD system used in conjunction with the currently approved Kainox A+ ICD lead. The device, as modified, will be marketed under the trade name Lumax 540 VR-T DX ICD and is indicated for providing ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life threatening ventricular arrhythmias.
P960009/S049
4/16/10
Activa Tremor Control System Medtronic Neuromodulation
Minneapolis, MN
55432
Approval of the post-approval study protocol.
P960009/S080
4/30/10
Special
Medtronic Activa® Parkinson’s Control Therapy Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for adding a warning to both the physician and patient manuals.
P960013/S054
4/14/10
180-Day
Tendris STS Lead St. Jude Medical, CRMD
Sylmar, CA
91342
Approval for the Tendril STS Model 1988TC lead.
P960040/S214
4/2/10
Real-Time
Teligen Pulse Generators Boston Scientific
St. Paul, MN
55112
Approval for 2 nd supplier (IXYS) to provide SCR/Anode gate Thyristors for the Super Output Module (SOM) of the Cognis/Teligen PGs.
P970003/S108
4/14/10
Special
VNS Therapy System Cyberonics®, Inc.
Houston, TX
77058
Approval for labeling changes for End of Service (EOS) Warning and low Impedance Warning.
P970004/S079
4/13/10
Real-Time
Medtronic InterStim® Therapy for Urinary Control Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for a change to the hub material of the Foramen needle in the Medtronic InterStim® Accessory kits (Models 041828, 041829, and 3065U).
P970004/S082
4/2/10
180-Day
InterStim Urinary Therapy Medtronic Neuromodulation
Minneapolis, MN
55432
Approval of the post-approval study protocol.
P970008/S048
4/30/10
Real-Time
Urologix Targis™ System for the Treatment of BPH Urologix, Inc.
Minneapolis, MN
55447
Approval for software changes to the Urologix Targis System CoolWave® Control Unit Model 5000A.
D970012/S076
4/30/10
Special
AMS 700™ Series Product Line Inflatable Penile Prostheses American Medical Systems, Inc.
Minnetonka, MN
55343
Approval for modifications to the Operating Room Manual to improve the pre-operative preparation instructions for the Momentary Squeeze (MS) Pump.
P970018/S018
4/2/10
180-Day
BD Prepstain System BD Diagnostic Systems
Durham, NC
27703
Approval for a manufacturing site located at TriPath Imaging, Inc., Mebane, North Carolina.
P970029/S017
4/15/10
Special
TMR2000 Holmium Laser System Cariogenesis Corporation
Irvine, CA
92618
Approval for modification of an existing warning statement to state: “Each Handpiece Delivery System is supplied sterile for single use only. Do not reuse or resterilize. Any attempt to clean and resterilize can damage the fiberoptic.”
P970051/S060
4/23/10
135-Day
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO
80111
Approval for modification of the methodology used for the final electrode testing of te CI500 series implant.
P980022/S068
4/5/10
Real-Time
Paradigm Real-Time Insulin Pump Medtronic, Inc.
Diabetes
Northridge, CA
91325
Approval for modification to the Paradigm Real-Time Insulin Pump to add an insulation pad to the pump motor flex cable and is indicated for continuous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition to delivery of insulin, the Paradigm Insulin Pump is designed to receive and display real-time glucose values received via a compatible transmitting device.
P980049/S050
4/7/10
180-Day
Paradym VR/DR ELA Medical, Inc.
Plymouth, MN
55441
Approval for the Paradym VR Model 8250 and DR Model 8550 with Smartview 2.18UG1 Programmer Software and the Paradym CRT-D Model 8750 with Hardware and Manufacturing Changes and Labeling and Programmer Software Changes to the Ovatio VR Model 6250, DR Model 6550 and CRT-D Model 6750. The device, as modified, will be
marketed under the trade name Paradym VR Model 8250 and Paradym DR Model 8550 with Smartview 2.18UG1 and is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent poorly tolerated sustained ventricular tachycardia.
P980049/S053
4/27/10
135-Day
Ovatio VR ICD and Ovatio DR ICD ELA Medical, Inc.
Plymouth, MN
55441
Approval for a change to the soldering and cleaning processes for the Shock 6 hybrid modules.
P990071/S011
4/7/10
Special
Stocked 70 Radiofrequency Ablation Generator with CoolFlow Irrigation Pump; Cool Flow Tubing Set Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for changes in the labeling made to the CoolFlow Irrigation Pump’s Tubing set.
P000040/S014
4/23/10
180-Day
GeneSys HTA™ System Boston Scientific Corporation
Urology & Women’s Health
Marlborough, MA
01752
Approval for the “next generation” HTA System with a redesigned operational unit (control unit, power cord, pedestal, IV pole) and a modified sterile procedure set. The device, as modified, will be marketed under the trade name GeneSys HTA System and is indicated for ablation of the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
P010012/S234
4/2/10
Real-Time
Cognis Pulse Generators Boston Scientific
St. Paul, MN
55112
Approval for 2 nd supplier (IXYS) to provide SCR/Anode gate Thyristors for the Super Output Module (SOM) of the Cognis/Teligen PGs.
P010032/S032
4/8/10
Real-Time
Eon mini Implantable Pulse Generator (IPG) Neurostimulation System Advanced Neuromodulation
Systems
Plano, TX
75024
Approval for the incorporation of a color additive to change the color of the pocket sizer to yellow, so that it would be more easily visible to the physician.
P020014/S029
4/6/10
180-Day
Conceptus Essure® System for Permanent Birth Control Conceptus, Inc.
Mountain View, CA
94041
Approval for updated micro-insert placement rates in the physician labeling resulting from the ESS305 post-approval study.
P030002/S022
4/30/10
Real-Time
Crystalens® Model AT-45 Accommodating Intraocular Lens (IOL) Bausch & Lomb, Inc.
Aliso Viejo, CA
92656
Approval to modify the Physician’s Labeling to include the addition of 0.25 diopter increments for the Crystalens Model AT50AO lenses in the +17 to +27 dioptric power range and for Model AT52AO lenses in the +16 to +16.75 dioptric power range.
P030011/S007
4/28/10
180-Day
SynCardia temporary Total Artificial Heart (TAH-t) SynCardia Systems, Inc.
Tucson, AZ
85713
Approval for the trade name change of the subject device. The device will be marketed under the trade name SynCardia temporary Total Artificial Heart and is indicated for use in transplant-eligible candidates in imminent danger of death from irreversible biventricular failure.
P030025/S069
4/27/10
135-Day
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a change in the stent coating process.
P030039/S015
4/5/10
Special
CoSeal Surgical Sealant and Accessories Baxter Healthcare Corporation
McGaw Park, IL
60085
Approval for changes to the labeling to address safety-related information.
P040001/S016
4/30/10
180-Day
X-STOP® Interspinous Process Spacer System Medtronic Spine LLC
Sunnyvale, CA
94089
Approval for additional surgical instruments, changes to existing instruments and a new sterilization tray. These new components include the Sizing Distractor, the Spacer Insertion Instrument with tri-lobe connectors, the Bi-directional Sizing Distractor, the Horizontal Handle, the Trial Spacers, and the Two-level Sterilization Tray.
P040003/S007
4/19/10
180-Day
Exablate 2100 Magnetic Resonance (MR) Guided Focused Ultrasound Insightec, Inc.
Dallas, TX
75244
Approval of the post-approval study protocol.
P040012/S031
4/30/10
180-Day
RX ACCULINK Carotid Stent System Abbott Vascular
Santa Clara, CA
95054
Approval for modifications to the indication statement and Instructions for Use to incorporate use with the Emboshield Embolic Protection System. The device, as modified, will be marketed under the trade name RX ACCULINK Carotid Stem System and is indicated for use in conjunction with Abbott Vascular's Accunet or Emboshield family of Embolic Protection Systems, for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria as previously approved.
P040023/S014
4/20/10
180-Day
Duraloc Option Ceramic Hip System Depuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval of the post-approval study protocol.
P040024/S045
4/7/10
135-Day
Restylane® Injectable Gel Medicis Pharmaceutical Corporation
Scottsdale, AZ
85256
Approval for changes in microbiological and environmental testing at the manufacturing sites in Sweden.
P050007/S024
4/22/10
Real-Time
StarClose® and StarClose® SE Vascular Closure Systems Abbott Vascular, Inc.
Redwood City, CA
94063
Approval for changes to the pouch design and packaging methods.
P050017/S005
4/12/10
Real-Time
Zilver® Vascular Stent and Zilver® Vascular Stent with Rapid Exchange Delivery System Cook, Inc.
Bloomington, IN
47402
Approval for revised product labeling.
P050023/S029
4/30/10
Real-Time
Lumax 540 VR-T DX Implantable Cardioverter Defibrillators Biotronik, Inc.
Lake Oswego, OR
97035
Approval for introduction of the Lumax 540 VR-T DX Implantable Cardioverter Defibrillator (ICD), a single lead ICD system used in conjunction with the currently approved Kainox A+ ICD lead. The device, as modified, will be marketed under the trade name Lumax 540 VR-T DX ICD and is indicated for providing ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life threatening ventricular arrhythmias.
P060001/S008
4/28/10
Special
PROTÉGÉ GPS and RX Carotid Stent Systems ev3 Endovascular, Inc.
Plymouth, MN
55441
Approval for the addition of a new material specification and an incoming inspection step for the annealed tantalum sphere components of the device.
P060002/S011
4/16/10
Special
FLAIR Endovascular Stent Graft Bard Peripheral Vascular, Inc.
Tempe, AZ
85280
Approval for modifications to the device Instructions for Use to include language to improve the safety in use of the device, predominantly with respect to the potential for device migrations.
P060008/S024
4/27/10
135-Day
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a change in the stent coating process.
P060022/S006
4/1/10
Real-Time
Akreos Advance Optics Aspheric Lens and Akreos AO Micro Incision Lens Bausch & Lomb
Rochester, NY
14609
Approval for design modifications to Model MI60L and use of Medicel VISCOJECT 2.2 LP60430 inserter with Model AO60 and is indicated for the replacement of the human crystalline lens in the visual correction of aphakia.
P060027/S015
4/7/10
180-Day
Paradym CRT-D and Ovatio VR/DR ELA Medical, Inc.
Plymouth, MN
55441
Approval for the Paradym VR Model 8250 and DR Model 8550 with Smartview 2.18UG1 Programmer Software and the Paradym CRT-D Model 8750 with Hardware and Manufacturing Changes and Labeling and Programmer Software Changes to the Ovatio VR Model 6250, DR Model 6550 and CRT-D Model 6750. The device, as modified, will be marketed under the trade name Paradym VR Model 8250 and Paradym DR Model 8550 with Smartview 2.18UG1 and is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent poorly tolerated sustained ventricular tachycardia.
P060027/S019
4/27/10
135-Day
Ovatio CRT-D ELA Medical, Inc.
Plymouth, MN
55441
Approval for a change to the soldering and cleaning processes for the Shock 6 hybrid modules.
P060033/S049
4/28/10
180-Day
Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Vascular
Santa Rosa, CA
95403
Approval of the post-approval study protocol.
P060040/S006
4/19/10
180-Day
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA
94588
Approval for a design change to the pump end bend relief (PEBR) region of the HeartMate II percutaneous lead.
P060040/S007
4/6/10
Real-Time
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA
94588
Approval for a repair kit (HM II PLRK) for the external portion of the HeartMate II percutaneous lead and a repair kit (Clam Shell) for the external bend relief.
P060040/S009
4/30/10
Special
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA
94588
Approval for providing additional information in the labeling regarding the proper procedure for making connections between the electrical power cables of the device.
P070007/S016
4/1/10
Real-Time
Talent Thoracic Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Approval for a change to the stent graft spring attachment tensile strength specification.
P070007/S017
4/30/10
Special
Talent Thoracic Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Approval for labeling changes regarding over sizing beyond current recommendations and the placement of bare springs inside of covered stent grafts.
P070015/S028
4/1/10
Real-Time
XIENCE V® Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92591
Approval for the In vivo In vitro Correlation (IVIVC) method for the device.
P070022/S002
4/15/10
180-Day
Adiana® Permanent Contraception System Hologic, Inc.
Marlborough, MA
01652
Approval for a manufacturing site located at Biotest Laboratories, Inc.
Minneapolis, Minnesota .
P070027/S015
4/29/10
180-Day
Talent Abdominal Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Approval of the post-approval study protocol.
P070027/S016
4/1/10
Real-Time
Talent Abdominal Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Approval for a change to the stent graft spring attachment tensile strength specification.
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N18033/S046
4/30/10
VISTAKON® (etafilcon A) Contact Lens Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Alternate suppler for the foil lidstock material.
P790017/S107
4/21/10
Sprinter Legend Rapid Exchange Balloon Dilatation Catheters Medtronic Vascular
Santa Rose, CA
95403
 
Additional vendor for a component of the device.
P810046/S236
4/23/10
Simpson-Robert® Coronary Balloon Dilatation Catheters (VOYAGER® and VOYAGER NC) Abbott Vascular
Temecula, CA
92591
Requested a change in manufacturing equipment used to coat the stent delivery system and balloon dilatation catheters.
P830061/S050
4/28/10
CapSure, CapSure Z Novus, STERx Tip Pacing Lead (ventricular), Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse, and Vitatron Impulse II Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P840001/S149
4/16/10
Restore Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Implementation of the QualityHold Business Rule within the FACTORY works manufacturing traceability system.
P840001/S150
4/30/10
Restore® Implantable Neurostimulators Medtronic, Inc.
Minneapolis, MN
55432
Addition of a supplier for the planting process.
P850089/S065
4/28/10
CapSure, CapSure Z Novus, STERx Tip Pacing Lead (ventricular), Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse, and Vitatron Impulse II Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P860004/S124
4/16/10
Synchromed Family of Implantable Infusion Pumps Medtronic Neuromodulation
Minneapolis, MN
55432
Implementation of the QualityHold Business Rule within the FACTORY works manufacturing traceability system.
P860019/S251
4/6/10
Maverick XL PTCA Dilatation Catheter Boston Scientific Corporation
Maple Grove, MN
55311
Change to the method used to create the proximal marks on the shaft of the stent delivery system.
P860019/S253
4/22/10
Maverick 2™ Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA Catheters) Boston Scientific Corporation
Maple Grove, MN
55311
Alternate manufacturing process flow for the device.
P880086/S186
4/23/10
Frontier/Frontier II Family of CRT-Ps St. Jude Medical
Sunnyvale, CA
94086
Change in automated manufacturing tests.
P890003/S187
4/28/10
CapSure, CapSure Model, Prodigy, Service Kit-Pacemaker Repair Kit, Thera-I, Vitatron Legacy, Vitatron Legacy II, and Vitatron Visa Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P900061/S088
4/28/10
Gem, PCD Tachy Control System, Jewel, Micro Jewel, Micro Jewel II, Oval Patch Lead, Epicardial Patch Lead Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P910023/S231
4/23/10
Cadence Family of ICDs St. Jude Medical
Sunnyvale, CA
94086
Change in automated manufacturing tests.
P910077/S103
4/1/10
Latitude™ Communicator RF Boston Scientific Corporation
St. Paul, MN
55112
Use of new test management system at device final test.
P920015/S059
4/28/10
Sprint, Sprint Fidelis, Sprint Quattro, Subcutaneous Lead, Sub-Q Defibrillation Lead, Transvene CS/SVC Lead, Transvene DF1 Lead, Transvene RV Lead, Transvene SubQ Lead, Transvene SVC Lead Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P930039/S036
4/28/10
CapSure, SureFix, Vitatron Crystalline ActFix, Vitatron Pirouet S+ Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P940034/S018
4/23/10
AMPLIFIED® MTD (Mycobacterium Tuberculosis Direct) Test Gen-Probe, Inc.
San Diego, CA
92121
Change of location for a QC lab to segregate the pre- and post-amplification steps into separate rooms.
P950018/S013
4/2/10
Perfluoron® Alcon Research, Ltd.
Fort Worth, TX
76134
Room changes, mechanical changes and an oven replacement.
P950020/S039
4/6/10
Coronary Flextome® Cutting Balloon® Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of a new coating process for mandrels.
P950024/S020
4/28/10
CapSure Epicardial Pacing Lead Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P950032/S057
4/9/10
Apligraf® Organogenesis, Inc.
Canton, MA
02021
Change in an alternate in-process tray assembly.
P960009/S079
4/30/10
Activa® Implantable Neurostimulators Medtronic, Inc.
Minneapolis, MN
55432
Addition of a supplier for the planting process.
P960016/S028
4/6/10
Livewire TC™ Cardiac Ablation System St. Jude Medical
Minnetonka, MN
55345
Replacement of the custom thermometer equipment used in the Sensor Test with off-the-shelf thermometer equipment.
P960040/S219
4/15/10
TELIGEN Family of ICDs Boston Scientific
St. Paul, MN
55112
Second source supplier for connector blocks.
P960040/S220
4/15/10
TELIGEN, CONFIENT and VITALITY Families of ICDs Boston Scientific
St. Paul, MN
55112
Changes to the hybrid cleaning process to align with other product lines.
P970004/S083
4/16/10
Interstim Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Implementation of the QualityHold Business Rule within the FACTORY works manufacturing traceability system.
P970004/S084
4/30/10
InterStim® Implantable Neurostimulator Medtronic, Inc.
Minneapolis, MN
55432
Addition of a supplier for the planting process.
P970008/S050
4/15/10
Urologix Targis System for the Treatment of BPH Urologix, Inc.
Minneapolis, MN
55447
Change in the cooling balloon bonding process.
P970012/S066
4/28/10
Kappa 400 Family Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
D970012/S075
4/22/10
AMS Ambicor® Penile Prosthesis American Medical Systems, Inc.
Minnetonka, MN
55343
Implementation of an additional, duplicate mold for a component of the assembly.
P970020/S055
4/23/10
MULTI-LINK ZETA® Coronary Stent System (CSS) Abbott Vascular
Temecula, CA
92591
Requested a change in manufacturing equipment used to coat the stent delivery system and balloon dilatation catheters.
P980016/S233
4/28/10
CapSure, Entrust, Gem, Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Secura, Virtuoso, and Virtuoso II Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P980016/S235
4/30/10
EnTrust ICD, Secura DR ICD, Secura VR ICD, Maximo II DR Maximo II VR, Virtuoso II DR ICD, Virtuoso ICD, Virtuoso II VR ICD Medtronic, Inc.
Mounds View, MN
55112
Addition of an alternate supplier for the gold planting process.
P980035/S163
4/28/10
350 Series, Adapta, AT500, EnPulse, EnRhythm, Kappa 600, Kappa 700, Kappa 800, Kappa 900, Relia, Sensia, Versa, and Sigma Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P980035/S164
4/30/10
EnRhythm IPG, Adapta, Versa, Sensia IPG, Relia IPG Medtronic, Inc.
Mounds View, MN
55112
Addition of an alternate supplier for the gold planting process.
P980049/S055
4/22/10
Isoline 2CR and Isoline 2CT Leads ELA Medical, Inc.
Plymouth, MN
55442
Change in incoming inspection procedure.
P980050/S048
4/28/10
Jewel AF, Gem III AT, and CS-SVD Transvene Lead Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P990001/S065
4/28/10
Clarity,
DA+ C-Series,
DA+ T-Series, Diamond 3, Diamond II, Jade 3, Jade II, Ruby 3, Ruby II,
Selection AFm, Topaz 3, Topaz II, Vita, and Vita 2 Families
Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P990034/S017
4/16/10
IsoMed Infusion Pumps Medtronic Neuromodulation
Minneapolis, MN
55432
Implementation of the QualityHold Business Rule within the FACTORY works manufacturing traceability system.
P000010/S015
4/8/10
Amplicor HCV Test, version 2.0 Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Room changes for the manufacture of Quantitation Standard and Internal Control Reagents.
P000010/S016
4/7/10
Amplicor HCV Test Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Changes to the CIP process for the bulk formulation tanks and their associated filling transfer lines, and minor modifications to the hopper equipment used in the formulation of bulk reagents for the device.
P000012/S022
4/8/10
Cobas Amplicor HCV Test, version 2.0 and Cobas AmpliPrep/Cobas Amplicor HCB Test, version 2.0 Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Room changes for the manufacture of Quantitation Standard and Internal Control Reagents.
P000021/S016
4/26/10
Dimension® TPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Replacement of the insulin supply used in the antibody growth media production process to compensate for a shortage.
P000039/S035
4/22/10
AMPLATZER® Septal Occluder and AMPLATZER® Exchange System AGA Medical Corporation
Plymouth, MN
55442
Addition of an alternate component supplier.
P000053/S028
4/23/10
AMS 800 Artificial Urinary Sphincter American Medical Systems
Minnetonka, MN
55343
Modification of a parameter in a receiving inspection test for silicone used in the coating process.
P010012/S238
4/15/10
COGNIS Family of CRT-Ds Boston Scientific
St. Paul, MN
55112
Second source supplier for connector blocks.
P010012/S239
4/15/10
COGNIS, LIVIAN and RENEWAL 3 Families of CRT-Ds Boston Scientific
St. Paul, MN
55112
Changes to the hybrid cleaning process to align with other product lines.
P010015/S083
4/28/10
Attain, InSync, and InSync III Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P010019/S013
4/1/10
Lotrafilcon Soft Contact lenses for Extended Wear CIBA Vision Corporation
Duluth, CA
30097
Change to the use of an automated vision inspection systems.
P010020/S015
4/23/10
Acticon Neosphincter Artificial Bowel Sphincter American Medical Systems
Minnetonka, MN
55343
Modification of a parameter in a receiving inspection test for silicone used in the coating process.
P010031/S192
4/28/10
Concerto, Concerto II, Consulta,
InSync ICD, InSync Marquis, InSync Maximo, InSync II Marquis, Maximo II, InSync II Protect, InSync III Marquis, and InSync Sentry Families
Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P010031/S194
4/30/10
Concerto II ICD, Consulta CRT-D, Maximo II CRT-D, Concerto CRT-D Medtronic, Inc.
Mounds View, MN
55112
Addition of an alternate supplier for the gold planting process.
P010047/S002
4/15/10
Neomend Progel Pleural Air Leak Sealant Neomend, Inc.
Irvine, CA
926178
Change from a manual manufacturing process to automated process for filling a component.
P020004/S051
4/14/10
Gore Excluder® AAA Endoprosthesis W.L. Gore & Associates
Flagstaff, AZ
86003
Modification to deployment force and tensile strength specifications for the device components.
P020011/S003
4/23/10
VERSANT® HCV RNA Qualitative Assay and APTIMA® HCV RNA Qualitative Assay Gen-Probe, Inc.
San Diego, CA
92121
Change of location for a QC lab to segregate the pre- and post-amplification steps into separate rooms.
P020024/S028
4/22/10
AMPLATZER® Duct Occluder and 180 Degree Delivery System AGA Medical Corporation
Plymouth, MN
55442
Addition of an alternate component supplier.
P020027/S011
4/26/10
Dimension® FPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Replacement of the insulin supply used in the antibody growth media production process to compensate for a shortage.
P020030/S006
4/29/10
Situs OTW UW28D Leads ELA Medical, Inc.
Plymouth, MN
55441
Change in laser welding energy monitoring.
P020047/S018
4/23/10
MULTI-LINK VISION® Family of Coronary Stent Systems (VISION® and MINI-VISION®) Abbott Vascular
Temecula, CA
92591
Requested a change in manufacturing equipment used to coat the stent delivery system and balloon dilatation catheters.
P030017/S101
4/6/10
Precision® Spinal Cord Stimulator (SCS) System Boston Scientific Neuromodulation Corporation
Valencia, CA
91355
Consolidation to a single component supplier for the Artisan 2X8 Surgical Lead Disc Electrode.
P030017/S103
4/28/10
Precision Spinal Cord Stimulator (SCS) System Artisan 2x8 Surgical Lead Boston Scientific Neuromodulation Corporation
Valencia, CA
91355
Use of a rework process within the production process to increase product yield.
P030035/S067
4/23/10
Affinity/Integrity/ Victory Family of Pacemakers St. Jude Medical
Sunnyvale, CA
94086
Change in automated manufacturing tests.
P030036/S016
4/28/10
SelectSecure Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P030049/S008
4/20/10
ADVIA Centaur HBsAg Assay Siemens Healthcare Diagnostics
East Walpole, MA
02032
Change of raw material used in the production of the Lite Reagent buffer.
P030054/S147
4/23/10
Epic HF/Atlas+ HF Family of CTR-Ds St. Jude Medical
Sunnyvale, CA
94086
Change in automated manufacturing tests.
P040040/S012
4/22/10
AMPLATZER® Muscular VSD Occluder AGA Medical Corporation
Plymouth, MN
55442
Addition of an alternate component supplier.
P040044/S029
4/28/10
Mynx® Vascular Closure Device Access Closure, Inc.
Mountain View, CA
94043
Adding a manufacturing process for the advancer tube component in-house.
P040044/S030
4/30/10
Mynx® Vascular Closure Device Access Closure, Inc.
Mountain View, CA
94043
Moving post-sterile activities associated with product handling, storage and shipping from one facility to another facility on the same street.
P040045/S013
4/30/10
VISTAKON® (senofilcon A) Contact Lenses Vistakon, Division of Johnson & Johnson Vision Care
Jacksonville, FL
]32256
Addition of a new supplier for soil lidding material.
P050028/S006
4/8/10
Cobas TaqMan HBV Test Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Room changes for the manufacture of Quantitation Standard and Internal Control Reagents.
P050044/S013
4/2/10
Vitagel Surgical Hemostatic Agent and Dressing Orthovita, Inc.
Malven, PA
19335
Alternate supplier for a component of the device.
P060006/S009
4/6/10
Express™ SD Renal Monorail™ Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Change to the method used to create the proximal marks on the shaft of the stent delivery system.
P060027/S022
4/29/10
Situs OTW UW28D Leads ELA Medical, Inc.
Plymouth, MN
55441
Change in laser welding energy monitoring.
P060030/S007
4/8/10
Cobas AmpliPrep/ Cobas TaqMan HCV Test Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Room changes for the manufacture of Quantitation Standard and Internal Control Reagents.
P060039/S011
4/28/10
Attain StarFix Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P070014/S011
4/13/10
Bard® Lifestent® Vascular Stent Systems Bard Peripheral Vascular, Inc.
Tempe, Az
85280
Addition of alternate tensile strength testing equipment.
P070015/S033
4/23/10
XIENCE V® Everolimus-Eluting Coronary Stent System (EECSS) and PROMUS® Everolimus-Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92591
Requested a change in manufacturing equipment used to coat the stent delivery system and balloon dilatation catheters.
P080006/S007
4/28/10
Attain Families Medtronic, Inc.
Mounds View, MN
55112
Addition of a business rule to the Manufacturing Execution System.
P080010/S005
4/28/10
TECNIS® Multifocal Foldable Posterior Chamber Intraocular Lens Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Change from manual to automated rotation during the hole-drilling step.
P080011/S003
4/7/10
Biofinity® (Comfilcon A) soft contact lenses for extended wear CooperVision, Inc.
Pleasanton, CA
94588
Addition of a new qualified vendor of the raw material for the device.

Summary of PMA Originals & Supplements Approved
Originals: 6
Supplements: 55

Summary of PMA Originals Under Review
Total Under Review: 80
Total Active: 35
Total On Hold: 45
Number Greater Than 180 Days: 5

Summary of PMA Supplements Under Review
Total Under Review: 574
Total Active: 357
Total On Hold: 217
Number Greater Than 180 Days: 18

Summary of All PMA Submissions Received
Originals: 5
Supplements: 50

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 55
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 110.8
FDA Time: 84.0 Days MFR Time: 26.8 Days

    
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