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PMA Final Decisions Rendered for May 2003 |
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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. Information about the PDF Reader is available.
| APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
|
5/23/03 |
Zenith™ AAA Endovascular Graft and H&L-B One-Shot™ Introduction System |
Cook, Inc. Bloomington, IN 47402 |
Approval for the Zenith™ AAA Endovascular Graft and H&L-B One-Shot™ Introduction System. The device is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair. |
| P020024 5/14/03 |
AMPLATZER® Duct Occluder and 180º Delivery System |
AGA Medical Corporation Golden Valley, MN 55427 |
Approval for the AMPLATZER® Duct Occluder and 180 degree Delivery System. The percutaneous, transcatheter occlusion device is indicated for the non-surgical closure of patent ductus arteriosus (PDA). |
|
5/7/03 |
Response™ CV Catheter System |
St. Jude Medical, Inc. Minnetonka, MN 55345 |
Approval for the Response™ CV Catheter System, which includes the following components: SJM Cardioversion Response™ (CV) Electrophysiology Catheter; SJM CV Electrophysiology Extension Cable; SJM Cardioversion Switchbox System; and SJM Cardioversion Cable. This system is indicated as follows: The SJM Cardioversion Response™ (CV) Electrophysiology Catheter when used with the SJM CV Electrophysiology Extension Cable and SJM Switchbox System is indicated for use in the invasive evaluation of cardiac arrhythmias and can be used for intracardiac cardioversion of atrial tachyarrhythmias. The SJM CV Electrophysiology Extension Cable is intended to connect a SJM Response™ (CV) Cardioversion Electrophysiology Catheter to a SJM Cardioversion Switchbox System. The SJM Cardioversion Switchbox System is intended to connect a SJM Cardioversion (CV) Electrophysiology Catheter and SJM CV Electrophysiology Extension Cable to a compatible cardioverter/ defibrillator and EP recording system. The SJM Cardioversion Cable is intended to connect the SJM Cardioversion Switchbox System to a compatible cardioverter. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P830045/S086 5/9/03 Real-Time |
Pulse Generator Models and Programmer Software Model 3307 v4.4a |
St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342 |
Approval for Pulse Generator Models and programmer software Model 3307 v4.4a. |
| P830061/S035 5/9/03 Real-Time |
Medtronic Models CapSure SP 4092, CapSure SP 4592, CapSure SP 4023, CapSure SP 4523 and CapSure Sense 4073; Vitatron Models Excellence PS+ IMK49B, Excellence PS+ IMK49JB, and Crystalline ICM09 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for material and labeling changes for various Medtronic and Vitatron pacing and defibrillator leads. |
| P840001/S067 5/9/03 Real-Time |
Itrel® II, Itrel® 3, Synergy™ and Synergy Versitrel™ Neurostimulators |
Medtronic Neurological Minneapolis, MN 55432 |
Approval for the Snap Lid Screening Cable, the Octad Percutaneous Extension and the Octad Stylet which are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs. |
| P840001/S068 5/9/03 Special |
Itrel®, Synergy™ and Synergy Versitrel™ Neurostimulators |
Medtronic Neurological Minneapolis, MN 55432 |
Approval for labeling changes to Pisces Z Quad lead technical manuals and a change to the needle in the Pisces Z Quad lead kits and in the Model 3550-22 and Model 3550-23 Accessory kits from 15 gauge to the 14 gauge. |
| P840064/S024 5/23/03 Special |
Viscoat® Ophthalmic Viscosurgical Device |
Alcon Research Ltd. Fort Worth, TX 76134 |
Approval for addition for the following precaution to the product insert: “Use only if the container is undamaged.” |
| P850022/S014 4/23/03 Special |
Biolectron OrthoPak® Bone Growth Stimulator and SpinalPak® Spinal Fusion Stimulator |
EBI, L.P. Parsippany, NJ 07054 |
Approval for additional labeling to emphasize the proper use of the device electrodes. |
| P850089/S051 5/9/03 Real-Time |
Medtronic Models CapSure SP 5023M, CapSure SP 5524M and CapSure Z 5033; Vitatron Models Excellence S+ IME49 and Impulse IMG49 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for material and labeling changes for various Medtronic and Vitatron pacing and defibrillator leads. |
| P860057/S019 5/9/03 180-Day |
Carpentier- Edwards® PERIMOUNT™ Pericardial Bioprosthesis, Models 2700, 2800, 6900 and 6900P |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for the replacement of the package temperature indicator. |
| P870072/S021 5/14/03 180-Day |
Thoratec Ventricular Assist Device (VAD) System |
Thoratec Corporation Pleasanton, CA 94588 |
Approval for the use of a reverse-engineered directional flow valve, to be manufactured at the site located in Pleasanton, California. |
| P870077/S013 5/9/03 180-Day |
Carpentier-Edwards® Duraflex® Low Pressure Mitral Bioprosthesis, Models 6625LP & 6625ESR-LP |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for the replacement of the package temperature indicator. |
| P880086/S094 5/9/03 Real-Time |
Pulse Generator Models and Programmer Software Model 3307 v4.4a |
St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342 |
Approval for Pulse Generator Models and programmer software Model 3307 v4.4a. |
| P890047/S015 5/23/03 Special |
Provisc® Ophthalmic Viscosurgical Device |
Alcon Research Ltd. Fort Worth, TX 76134 |
Approval for addition for the following precaution to the product insert: “Use only if the container is undamaged.” |
| P910001/S023 5/2/03 180-Day |
CVX-300 Excimer Laser Coronary Angioplasty (ELCA) System |
Spectranetics Corporation Colorado Springs, CO 80907 |
Approval for the revised Instructions for Use that include the adjudicated results from the LARS investigation. |
| P910023/S067 5/9/03 Real-Time |
Pulse Generator Models and Programmer Software Model 3307 v4.4a |
St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342 |
Approval for Pulse Generator Models and programmer software Model 3307 v4.4a. |
|
5/23/03 Panel |
STAR S4 ActiveTrak™ Excimer Laser System and WaveScan WaveFront® System |
VISX, Inc. Santa Clara, CA 95051 |
Approval for the VIXX STAR S4 ActiveTrak ™ Excimer Laser System and WaveScan WaveFront® System. The device uses a 6.00 mm optical zone, an 8.00 mm treatment zone, and is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) for: 1) the reduction or elimination of myopic astigmatism up to -6.00 D MRSE, with cylinder between 0.00 and -3.00 D; 2) patients 21 years of age or older; and 3) patients with documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination. |
| P930021/S007 5/20/03 180-Day |
Emdogain™ Gel |
Biora, Inc. Chicago, IL 60610 |
Approval of the additional indications for use as an adjunct to periodontal surgery for mandibular Class II furcations with minimal interproximal bone loss. |
| P930038/S036 5/2/03 Real-Time |
Angio-Seal™ Vascular Closure Device STS Platform and Angio-Seal™ Vascular Closure Device STS PLUS Platform |
St. Jude Medical, Inc. Minnetonka, MN 55345 |
Approval for modifying and standardizing the absorbable anchor component of the device so that the same component could be used in either marketed platform. |
| P930039/S014 5/9/03 Real-Time |
Medtronic Models CapSureFix 5568, CapSureFix 5068, and CapSureFix 5067, Vitatron Models Pirouet IMX49JB, Pirouet IMX49B, and Pirouet IMX49 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for material and labeling changes for various Medtronic and Vitatron pacing and defibrillator leads. |
| P950024/S006 5/9/03 Real-Time |
Medtronic Model CapSureEpi 4965 and CapSureEpi 4968 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for material and labeling changes for various Medtronic and Vitatron pacing and defibrillator leads. |
| P960006/S008 5/30/03 Real-Time |
FLEXTEND Bipolar, Steroid Eluting, Extendable/ Retractable Pacing Lead |
Guidant Corporation St. Paul, MN 55112 |
Approval for change in the durometer hardness. |
| P960043/S045 5/16/03 Special |
Perclose AT 6 French Suture Mediated Closer (SMC) System, and Perclose AT Monofilament 6 French Suture Mediated Closer (SMC) System |
Abbott Laboratories Redwood City, CA 94063 |
Approval for introducing a new test method to evaluate the link to cuff joint strength. |
| D970003/S021 5/15/03 Real-Time |
INSIGNIA I Entra and Plus Implantable Pacemaker System |
Guidant Corporation St. Paul, MN 55112 |
Approval for modifications to the INSIGNIA I Entra and Plus Implantable Pacemaker System as follow: 1) Alternate Medium Battery; 2) DIGIC with firmware versions 1.08 patch 13.0, 1.20 patch 14.0, and 1.25; and 3) Application software versions 1.20 and 1.21. |
| P970018/S006 5/2/03 180-Day |
PrepStain™ System |
TriPath Imaging, Inc. Redmond, WA 98052 |
Approval to modify the current approved labeling to include data and information from a direct-to-vial clinical study for High Grade Squamous Intraepithelial and more severe lesions. |
| P970021/S006 5/7/03 180-Day |
GYNECARE THERMACHOICE™ III Uterine Balloon Therapy System |
GYNECARE, A Division of ETHICON, Inc. Somerville, NJ 08876 |
Approval for a material change to the silixone balloon. The device, as modified, will be marketed under the trade name GYNECARE THERMACHOICE™ III Uterine Balloon Therapy System. |
| P980016/S032 5/9/03 Real-Time |
Medtronic Model CapSureFix 6940 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for material and labeling changes for various Medtronic and Vitatron pacing and defibrillator leads. |
| P980023/S014 5/14/03 180-Day |
Cardiac Airbag and Cardiac Airbag-T ICDs and Programmer Software CA-K00.1.u |
BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Approval for the Cardiac Airbag and Cardiac Airbag-AT and are intended to provide ventricular defibrillation for automated treatment of life-threatening arrhythmias in individuals not expected to have greater than 3 episodes of ventricular arrhythmias requiring ICD therapy during the anticipated lifetime of the device. |
| P980053/S005 5/28/03 180-Day |
Durasphere™ Injectable Bulking Agent |
Carbon Medical Technologies, Inc. St. Paul, MN 55110 |
Approval for marketing Durasphere™ packaged in 3 ml syringes. |
| P990001/S012 5/20/03 180-Day |
Model VSA02/VSC02 v9.0 Programming Software for the Diva, Dema, and Selection AFm Model 902 Pulse Generators |
Vitatron, Inc. Minneapolis, MN 55432 |
Approval for the Model VSA02/VSC02 v9.0 Programming Software for the Diva, Dema, and Selection AFm Model 902 Pulse Generators including the upgrade of the Selection AFm Model 902 to include ventricular Rate Stabilization. |
| P990020/S013 5/23/03 180-Day |
The AneuRx™ Stent Graft with Xpedient Delivery System |
Medtronic AVE Santa Rosa, CA 95403 |
Approval of modifications to the post-approval study for the device. |
| P990037/S015 5/20/03 Real-Time |
Duett™ Pro Sealing Device (Model 1010) and Diagnostic Duett™ Pro Sealing Device (Model 2210) |
Vascular Solutions, Inc. Minneapolis, MN 5441 |
Approval for a design change to the Deutt™ Pro Sealing Device and the Diagnostic Duett™ Pro Sealing Device. |
| P990037/S018 5/27/03 180-Day |
Duett™ Pro Sealing Device, Diagnostic Duett™ Pro Sealing Device and D-Stat Flowable Hemostat |
Vascular Solutions, Inc. Minneapolis, MN 5441 |
Approval for a manufacturing site located at Vascular Solutions, Inc., Minneapolis, Minnesota. |
| P990055/S006 5/9/03 Real-Time |
ACS: 180® and ADVIA Centaur® Complexed PSA (cPSA) Immunoassays |
Bayer Diagnostics Terrytown, NY 10591 |
Approval for labeling changes to the ACS: 180® and ADVIA Centaur® Complexed PSA (cPSA) Immunoassays. |
| P000007/S003 5/9/03 180-Day |
Edwards Prima Plus Stentless Bioprosthesis, Model 2500P |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for the replacement of the package temperature indicator. |
| P000009/S007 5/29/03 180-Day |
Tachos ATx Implantable Cardioverter Defibrillator System and programmer Software |
BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Approval for modifications to the Tachos DR Atrial Tx Implantable Cardioverter Defibrillator System. The device, as modified, will be marketed under the trade name, Tachos ATx and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening arrhythmias. The device is indicated for use in ICD patients either with atrial tachyarrhythmias or who are at risk of developing atrial tachyarrhythmias. |
| P010013/S005 5/27/03 Real-Time |
NovaSure™ Impedance Controlled Endometrial Ablation System |
Novacept, Inc. Palo Alto, CA 94303 |
Approval for removal of the option to override the Cavity Integrity Assessment System. |
| P010015/S010 5/9/03 Real-Time |
Medtronic Model 4193 Attain OTW Lead |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for material and labeling changes for various Medtronic and Vitatron pacing and defibrillator leads. |
| P010022/S003 5/6/03 Real-Time |
CoSeal™ Surgical Sealant (Original and Pre-Mixed) |
Cohesion Technologies, Inc. Palo Alto, CA 94303 |
Approval for modified real-time stability protocols and real-time commercial lot aging protocols to include mechanical and viscosity testing. |
| P010041/S002 5/9/03 180-Day |
Carpentier-Edwards® S.A.V. Porcine Bioprosthesis, Model 2650 |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for the replacement of the package temperature indicator. |
| P020004/S002 5/5/03 180-Day |
EXCLUDER™ Bifurcated Endoprosthesis |
W.L. Gore & Associates Flagstaff, AZ 86001 |
Approval for a modification made to the material of the deployment line of the delivery system for the EXCLUDER™ Bifurcated Endoprosthesis. |
| P020007/S001 5/15/03 180-Day |
Medtronic AVE Bridge™ Extra Support OTW Renal Stent System |
Medtronic AVE, Inc. Santa Rosa, CA 95403 |
Approval of the post-approval study for the device. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790017/S080 5/2/03 |
Stormer Z Balloon Dilatation Catheter, NC Stormer Z Balloon Dilatation Catheter |
Medtronic AVE Santa Rosa, CA 95403 |
Change to the adhesion process for the Z-component in the manufacture of the devices. |
| P810006/S021 5/5/03 |
Collastat Absorbable Collagen Hemostatic Sponge and Fibrillar Form |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Changes effecting manufacturing processes including: 1) qualifying additional manufacturing space, 2) the processing vessels, 3) use of an additional manufacturing area, and 4) modifying the drying process. |
| P840062/S008 5/16/03 |
CollaCote, CollaPlug, CollaTape Absorbable Collagen Wound Dressings for Dental Surgery |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Changes affecting manufacturing processes including: 1) qualifying additional manufacturing room, 2) modifying the temperature monitoring method, 3) addition of a different agent for cleansing the manufacturing area, and 4) modifying the drying process. |
| P850010/S018 5/5/03 |
Helistat Absorbable Collagen Hemostatic Sponge and Fibrillar Form |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Changes effecting manufacturing processes including: 1) qualifying additional manufacturing space, 2) the processing vessels, 3) use of an additional manufacturing area, and 4) modifying of the drying process. |
| P850020/S018 5/30/03 |
PROSORBA® Column |
Fresenius HemoCare, Inc. Redmond, WA 98052 |
Changes to the sterilization load configuration and length of sterilization cycle. |
| P860047/S013 5/8/03 |
Ocucoat® (2% Hydroxypropyl-methylcellulose Solution) |
Bausch & Lomb San Dimas, CA 91773 |
Change in the sterilization cycle parameters for Ocucoat as it is sterilized by Abbott Laboratories. |
| P890014/S005 5/6/03 |
DiaSorin ETI-HA-IGMK PLUS |
DiaSorin, Inc. Stillwater, MN 55082 |
Change in the quantity of non-specific mouse IgG used in the preparation of the Sample Diluent, Positive Control and Negative Control kit reagents of the DiaSorin ETI-HA-IGMK PLUS. |
| P900033/S009 5/5/03 |
INTEGRA Dermal Regeneration Template |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Changes effecting manufacturing processes including: 1) qualifying additional manufacturing space, 2) the processing vessels, 3) use of an additional manufacturing area, and 4) modifying of the drying process. |
| P950034/S025 5/28/03 |
Seprafilm® Adhesion Barrier and Seprafilm® Procedure Pack |
Genzyme Corporation Cambridge, MA 02139 |
Manufacturing process change to extend the endotoxin specification limit of Hyaluronic Acid (HA) raw material from ≤0.04 EU/mg to ≤0.08 EU/mg. |
| P970035/S045 5/2/03 |
S7 Zipper MX Coronary Stent System, S660 Zipper MX Coronary Stent System |
Medtronic AVE Santa Rosa, CA 95403 |
Change to the adhesion process for the Z-component in the manufacture of the devices. |
| P980031/S005 5/30/03 |
INTACS® Prescription Inserts |
Addition Technology, Inc. Sunnyvale, CA 94089 |
Implementing the outsourcing of the inspection, cleaning and packaging operations for INTACS® inserts to the qualified contract manufacturer, Biotest Laboratories, Inc. |
| P990044/S004 5/7/03 |
DiaSorin ETI-CORE-IGMK PLUS |
DiaSorin, Inc. Stillwater, MN 55082 |
Change in the quantity of non-specific mouse IgG used in the preparation of the Sample Diluent, Positive Control and Negative Control kit reagents of the DiaSorin ETI-CORE-IGMK PLUS. |
| P000039/S005 5/13/03 |
AMPLATZER® Septal Occluder, AMPLATZER® 45 º Delivery and Exchange Systems |
AGA Medical Corporation Golden Valley, MN 55427 |
Alternate supplier for the end screw attachment of the device as well as the delivery cable distal end screw, and proximal screw attachment on the delivery cable. |
| P000046/S008 5/22/03 |
STAARVISC™ II, SHELLGEL™ and CoEase™ |
Anika Therapeutics, Inc. Woburn, MA 01801 |
Manufacturing change for an additional process control treatment for STAARVISC™ II, SHELLGEL™ and CoEase™. |
| P010033/S005 5/12/03 |
QuantiFERON-TB |
Cellestis, Inc. Valencia, CA 91355 |
Change the supplier for Phytohaemagglu-tinin (PHA-P), which is used to formulate the Mitogen component in the QuantiFERON-TB kit. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 39
Summary of PMA Originals Under Review
Total Under Review: 75
Total Active: 29
Total On Hold: 46
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 220
Total Active: 108
Total On Hold: 112
Number Greater Than 180 Days: 3
Summary of All PMA Submissions Received
Originals: 6
Supplements: 37
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): 100.9
FDA Time: 96.8 Days MFR Time: 4.1 Days
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