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PMA Final Decisions Rendered for July 2000 |
 |
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 |
DEVICE DESCRIPTION / INDICATIONS |
|
6/14/00 |
Medtronic® Jewel® AF 7250 Dual Chamber Implantable Cardioverter Defibrillator, Model 9961 Programmer Application Software and Medtronic® Sprint™ Model 6943 Steroid Eluting, Screw-in, Atrial/Ventricular Lead |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for the Medtronic® Jewel® AF 7250 Dual Chamber Implantable Cardioverter Defibrillator (ICD), Model 9961 Programmer Application Software, and Medtronic® sprint™ Model 6943 Steroid Eluting, Screw-in, Atrial/Ventricular Lead. This system is indicated for use in ICD patients either with atrial tachyarrhythmias or who are at significant risk of developing atrial tachyarrhythmias. |
|
6/30/00 |
Diomed 630 PDT Laser, Model T2USA |
QLT PhotoTherapeutics, Inc. Washington, DC 20004 |
Approval for the Diomed 630 PDT Laser, Model T2USA. This device is indicated for use in Photodynamic Therapy with PHOTOFRIN (porfimer sodium) as a source of activation of PHOTOFRIN for: a) palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy, b) reduction of obstructing and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC), and c) treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated. |
|
6/15/00 |
NAVI-STAR® Diagnostic/Ablation Deflectable Tip Catheter |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for the NAVI-STAR® Diagnostic/Ablation Deflectable Tip Catheter. The device and related accessory devices are indicated for catheter-based atrial and ventricular cardiac mapping, and when used with a compatible radio frequency generator in adults and children 4 years of age and older for: *interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; including persistent junctional re-entrant tachycardia (PJRT) and Mahaim fibers; * the treatment of AV nodal re-entrant tachycardia; and *creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia. |
|
6/13/00 |
CoStasis® Surgical Hemostat and DynaStat™ Surgical Hemostat |
Cohesion Technologies Palo Alto, CA 94303 |
Approval for CoStasis® Surgical Hemostat and DynaStat™ Surgical Hemostat. The device is indicated for use in surgical procedures (other than in neurosurgical, ophthalmic, and urological) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. |
|
6/22/00 |
Vascular Solutions Duett™ Sealing Device |
Vascular Solutions, Inc. Minneapolis, MN 55441 |
Approval for the Vascular Solutions Duett™ Sealing Device. The device is indicated for sealing femoral arterial puncture sites and reducing time to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using a 5F – 9F introducer sheath with an overall length not exceeding 15.2 cm. |
|
6/30/00 |
Sunrise HYPERION™ LTK System |
Sunrise Technologies, Inc. Fremont, CA 94538 |
Approval for the Sunrise HYPERION™ LTK System. The device is indicated for temporary reduction of hyperopia in patients with +0.75 to +2.5 diopters of manifest refraction spherical equivalent (MRSE) at the spectacle plane (with cylinder less than or equal to +-0.75 diopters) who are 40 years of age of older with documented stability of refraction for the prior 6 months, as demonstrated by a change of less than or equal to 0.50D in spherical and cylindrical components of the manifest refraction. The magnitude of correction with this treatment diminishes over time, with some patients retaining some of all of their refractive correction. |
PMA/PDP SUPPLEMENTAL APPROVALS | |||
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME | DEVICE DESCRIPTION / INDICATIONS |
|
N17004/S012 6/20/00 Real-Time |
Surgical Simplex® P Radiopaque Bone Cement |
Stryker Instruments Kalamazoo, MI 49001 |
Approval for change to the packaging of the product. |
|
N50510/S131 6/6/00 180-Day |
Vitek® 2 Streptococccus pneumoniae Susceptibility Test for Cefotaxine |
BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for the addition of the antibiotic cefotaxime at concentrations of 0.06, 0.25, 0.5 and 1 micrograms/ml to the Vitek® 2 S. pneumoniae Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 S. pneumoniae Susceptibility Test Cards for use in the Vitek® 2 system and is indicated for use for the susceptibility testing of Streptococcus pneumoniae to cefotaxime in the range of <=0.06 to >=4 micrograms/ml. |
|
N50510/S132 6/8/00 180-Day |
Vitek® Streptococcus pneumoniae Susceptibility Test for Chloramphenicol |
BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for the addition of the antibiotic chloramphenicol at concentrations of 2, 8 and 16 micrograms/ml to the Vitek® 2 S. pneumoniae Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 S. pneumoniae Susceptibility Test Cards for use in the Vitek® 2 system and is indicated for use for the susceptibility testing of Streptococcus pneumoniae to chloramphenicol in the range of <=2 to >=32 micrograms/ml. |
|
N50510/S133 6/9/00 180-Day |
Vitek® 2 Streptococcus pneumoniae Susceptibility Test for Bensylpenicillin |
BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for the addition of the antibiotic bensylpenicillin at concentrations of 0.03, 0.06, 0.25 and 0.5 micrograms/ml to the Vitek® 2 S. pneumoniae Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 S. pneumoniae Susceptibility Test Cards for use in the Vitek® 2 system and is indicated for use for the susceptibility testing of Streptococcus pneumoniae to benzylpenicillin in the range of <=0.06 to >=2 micrograms/ml. |
|
N50510/S134 6/14/00 180-Day |
Vitek® 2 Streptococcus pneumoniae Susceptibility Test for Erythromycin |
BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for the addition of the antibiotic erythromycin at concentrations of 0.12, 0.25 and 0.5 micrograms/ml to the Vitek® 2 S. pneumoniae Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 S. pneumoniae Susceptibility Test Cards for use in the Vitek® 2 system and is indicated for use for the susceptibility testing of Streptococcus pneumoniae to erythromycin in the range of <=0.06 to >=1 micrograms/ml. |
|
N50510/S135 6/21/00 180-Day |
Vitek® 2 Streptococcus pneumoniae Susceptibility Test for Ceftriaxone |
BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for the addition of the antibiotic ceftriaxone at concentrations of 0.06, 0.25, 0.5 and 1 micrograms/ml to the Vitek® 2 S. pneumoniae Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 S. pneumoniae Susceptibility Test Cards for use in the Vitek® 2 system and is indicated for use for the susceptibility testing of Streptococcus pneumoniae to ceftriaxone in the range of <=0.06 to >=4 micrograms/ml. |
|
N50510/S136 6/21/00 180-Day |
Vitek® 2 Streptococcus pneumoniae Susceptibility Test for Tetracycline |
BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for the addition of the antibiotic tetracycline at concentrations of 0.5, 1 and 2 micrograms/ml to the Vitek® 2 S. pneumoniae Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 S. pneumoniae Susceptibility Test Cards for use in the Vitek® 2 system and is indicated for use for the susceptibility testing of Streptococcus pneumoniae to tetracycline in the range of <=1 to >=16 micrograms/ml. |
|
N50510/S137 6/21/00 180-Day |
Vitek® 2 Streptococcus pneumoniae Susceptibility Test for Ofloxacin |
BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for the addition of the antibiotic ofloxacin at concentrations of 1, 2 and 4 micrograms/ml to the Vitek® 2 S. pneumoniae Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 S. pneumoniae Susceptibility Test Cards for use in the Vitek® 2 system and is indicated for use for the susceptibility testing of Streptococcus pneumoniae to ofloxacin in the range of <=1 to >=8 micrograms/ml. |
|
N50510/S139 6/26/00 180-Day |
Vitek® 2 Streptococcus pneumoniae Susceptibility Test for Trimethoprim/Sulfamethoxazole |
BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for the addition of the antibiotic Trimethoprim/Sulfamethoxazole at concentrations of 2/38, 8/152, 16/304 and 32/608 micrograms/ml to the Vitek® 2 S. pneumoniae Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 S. pneumoniae Susceptibility Test Cards for use in the Vitek® 2 system and is indicated for use for the susceptibility testing of Streptococcus pneumoniae to Trimethoprim/Sulfamethoxazole in the range of <=0.5/9.5 to >=16/304 micrograms/ml. |
|
P790005/S043 6/23/00 Real-Time |
OsteoGen® Implantable Bone Growth Stimulator |
EBI, L.P. (EBI) Parsippany, NJ 07054 |
Approval for a change from a lithium iodine battery (CRC 1935M) to a lithium manganese battery (Renata, CR-0232AMT207-1) in the OsteoGen Bone Growth Stimulators. |
|
P810002/S052 6/30/00 180-Day |
St. Jude Medical ® Master Series Valve |
St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval to remove the condition of approval in the July 23, 1998 approval order that the firm provide results from tests which demonstrate the long-term integrity of the sewing cuff attachment mechanism of the St. Jude Medical® Master Series valve models. |
|
P810046/S201 6/5/00 180-Day |
CrossSail™ and OpenSail™ Coronary Dilatation Catheters |
Guidant Corporation Santa Clara, CA 95054 |
Approval for the CrossSail™ and OpenSail™ Coronary Dilatation Catheters. The catheters are indicated for: (a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and (b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction. |
|
P830045/S069 6/15/00 Real-Time |
Model 3264 Rev. B Programmer Software for the APSu Model 3250 Programmer |
St. Jude Medical Sylmar, CA 91342 |
Approval for the Model 3264 Rev. B Programmer Software for the APSu Model 3250 Programmer. |
|
P830045/S070 6/26/00 Real-Time |
Model 3307 v1.2a Programmer Software for the Model 3500/3510 Programmers |
St. Jude Medical Sylmar, CA 91342 |
Approval for Model 3307 v1.2a Programmer Software for the Model 3500/3510 Programmers. |
|
P830055/S074 6/22/00 Real-Time |
LCS Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for minor design modifications to the Rotating Platform Tibial Trays and bearings that were originally submitted and approved as part of supplements 47, 61, and 69. |
|
P840001/S045 6/13/00 Real-Time |
Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ Implantable Pulse Generators |
Medtronic Neurological Minneapolis, MN 55421 |
Approval for expansion of the Indications for Use for the Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ devices. These devices are indicated "as an aid in the management of chronic intractable pain of the trunk and limbs, including chronic and intractable unilateral or bilateral pain associated with the following: failed back syndrome or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome, post-laminectomy pain, multiple back operations, unsuccessful disc surgery, and degenerative disc disease (DDD)/herniated disc pain refractory to conservative and surgical interventions." |
|
P850035/S028 6/23/00 Real-Time |
SpF® 2T, 4T, and XLIIb Spinal Fusion Simulators |
EBI, L.P. (EBI) Parsippany, NJ 07054 |
Approval for a change from a lithium iodine battery (CRC 1935M) to a lithium manganese battery (Renata, CR-2032AMT207-1) in your SpF® 2T, 4T, and XLIIb Spinal Fusion Simulators. |
|
P860019/S164 6/29/00 180-Day |
Boston Scientific/ Scimed PTCA Catheters |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Approval for an alternate sterilization facility at IBA (formerly Griffith Micro Science, Inc.) Willowbrook, Illinois 60521. |
|
P870049/S030 6/5/00 Special |
MicroScan® Rapid Fluorogenic Panels |
Dade MicroScan, Inc. West Sacramento, CA 95691 |
Approval for a labeling change that adds a contraindication to the gram negative MicroScan® Rapid Fluorogenic Panels of "Do Not Report" when testing all gram negative organisms with cefoperazone using either the MIC or Breakpoint formats. |
|
P880006/S031 6/15/00 Real-Time |
Model 3264 Rev. B Programmer Software for the APSu Model 3250 Programmer |
St. Jude Medical Sylmar, CA 91342 |
Approval for the Model 3264 Rev. B Programmer Software for the APSu Model 3250 Programmer. |
|
P880006/S032 Real-Time |
Model 3307 v1.2a Programmer Software for the Model 3500/3510 Programmers |
St. Jude Medical Sylmar, CA 91342 |
Approval for Model 3307 v1.2a Programmer Software for the Model 3500/3510 Programmers. |
|
P880072/S047 6/20/00 180-Day |
Posterior Chamber Intraocular Lenses |
Medical Developmental Research, Inc. Clearwater, FL 33763 |
Approval for the manufacturing facility located at Medical Developmental Research, Inc., Clearwater, Florida 33763. |
|
P880086/S072 6/15/00 Real-Time |
Model 3264 Rev. B Programmer Software for the APSu Model 3250 Programmer |
St. Jude Medical Sylmar, CA 91342 |
Approval for the Model 3264 Rev. B Programmer Software for the APSu Model 3250 Programmer. |
|
P880086/S073 6/26/00 Real-Time |
Model 3307 v1.2a Programmer Software for the Model 3500/3510 Programmers |
St. Jude Medical Sylmar, CA 91342 |
Approval for Model 3307 v1.2a Programmer Software for the Model 3500/3510 Programmers. |
|
P900007/S002 6/12/00 180-Day |
Cook Chorionic Villus Sampling Set (CVS) |
Cook Ob/Gyn Spencer, IN 47460 |
Approval for a smaller size CVS set (5.3 Fr, 24 cm). |
|
P900009/S009 6/22/00 180-Day |
Sonic Acceelerated Fracture Healing System (SAFHS®) Model 2000, Exogen 2000 |
Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for the manufacturing ficility at Smith & Nephew, Inc., Memphis, Tennessee 38116. |
|
P900023/S033 6/22/00 180-Day |
ABIOMED® BVS 5000® Bi-Ventricular Support System |
ABIOMED, Inc. Danvers, MA 01923 |
Approval for a 36 French polyurethane arterial cannula with a stainless steel wire reinforced coil and a 10 mm Hemashield® graft. |
|
P900060/S020 6/29/00 180-Day |
Carbomedics® Prosthetic Heart Valve (CPHV™) Models 500 and 700, CPHV™ Reduced Aortic Model R500, CPHV™ Supra-Annular Models S500 and S700, Carbo-Seal® Ascending Aortic Prosthesis (AAP) Models AP21-AP33, Sulzer Carbomedics Orbis™ Prosthetic Heart Valve Models 100 and 200, and CPHV™ OptiForm™ Valve Models F500 and F700 |
Sulzer Carbomedics, Inc. Austin, TX 78752 |
Approval for the use of a nitinol lock wire as an alternative material for the sewing cuff attachment mechanism of the products listed. |
|
P920014/S012 6/23/00 Real-Time |
HeartMate® IP and VE LVAS |
Thermo Cardiosystems, Inc. Woburn, MA 01888 |
Approval for Outflow Graft Bend Relief (OGBR) and for a modification to the stand alone outflow graft. |
|
P940022/S015 6/16/00 180-Day |
CLARION® Multi- Strategy Cochlear Implant (Adult) |
Advanced Bionics® Corporation Sylmar, CA 91342 |
Approval for the fabrication process change for the integrated circuits in the device. |
|
P940031/S024 6/20/00 Real-Time |
DISCOVERY™/ MERIDIAN™ Family of Pacemakers |
Guidant Corporation St. Paul, MN 55112 |
Approval to market both coated and uncoated versions of the pacemaker. |
|
P950001/S007 6/29/00 Real-Time |
SELUTE® Picotip™ Atrial J Steroid Eluting Pacing Leads, Models 4063 and 4064 |
Guidant Corporation St. Paul, MN 55112 |
Approval for changes to the lead stabilizer component. |
|
P950018/S004 6/15/00 180-Day |
PERFLUORON |
Alcon Reasearch, Ltd. Fort Worth, TX 76134 |
Approval for the filter sterilization and aseptic fill facility located at Chesapeake Biological Laboratories (CBL), Inc., Baltimore, MD 21230. |
|
6/20/00 180-Day |
Apligraf (Graftskin) |
Organogenesis, Inc. Canton, MA 02021 |
Approval for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure. |
|
P950032/S017 6/16/00 Real-Time |
Living Skin Equivalence (LSE) Graftskin |
Organogenesis, Inc. Canton, MA 02021 |
Approval for a change in the description of Apligraf from the term "viable" to the term "living". |
|
P950035/S007 6/23/00 Real-Time |
NeuroControl Freehand® System |
NeuroControl Corporation Valley View, OH 44125 |
Approval for the distribution of an Implant Tester accessory which is used in final device testing at the completion of surgery. |
|
P950037/S011 6/28/00 Real-Time |
Actros+ and Kairos Pulse Generators |
BIOTRONIC, Inc. Lake Oswego, OR 97035 |
Approval for the use of a different substrate material (DYCOstrate®). |
|
P950037/S012 6/22/00 Real-Time |
Philow Pulse Generator Family and SWM1000 B-K000.0.U Software Cartridge |
BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Approval for the Philos Pulse Generator Family and the SWM1000 B-K000.0.U Software Cartridge. The device, as modified, will be marketed under the trade names Philos DR, Philos DR-B, Philos D, Philos SR, Philos SR-B, Philow S, Philos SLR, and the SWM1000 B-K00.0.U Software Cartridge. |
|
P960004/S013 6/9/00 180-Day |
ThinLine™ II/ FINELINE™ II Leads |
Guidant Corporation St. Paul, MN 55112 |
Approval for the manufacturing facility located at Guidant Puerto Rico B.V., Dorado, Puerto Rico 00646. |
|
P960058/S013 6/16/00 180-Day |
CLARION® Multi-Strategy Cochlear Implant (Pediatric) |
Advanced Bionics® Corporation Sylmar, CA 91342 |
Approval for the fabrication process change for the integrated circuits in the device. |
|
D970003/S011 6/20/00 Real-Time |
PULSAR™/ PULSAR MAX™ Family of Pacemakers |
Guidant Corporation St. Paul, MN 55112 |
Approval to marker both coated and uncoated versions of the pacemakers. |
|
P970004/S010 6/28/00 Real-Time |
Medtronic® Interstim® System for Urinary Control |
Medtronic, Inc. Minneapolis, MN 55421 |
Approval for 1) inclusion of depth indicators along the body of the Model 3057 Test Stimulation lead and associated labeling changes (3057 Test Stimulation Components Manual and 3065U Manual), and 2) other minor labeling changes to these manuals for clarification of instructions and minor refinements to the lead testing specification. |
|
P970008/S013 6/5/00 180-Day |
Urologix Targis™ System |
Urologix, Inc. Minneapolis, MN 55447 |
Approval for the 28.5 minute treatment option. |
|
P970015/S011 6/6/00 180-Day |
INTER FIX™ III Threaded Fusion Device |
Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for addition of holes in the endcaps of the INTER FIX™ Threaded Fusion Device. |
|
P970020/S024 6/23/00 Real-Time |
ACS Multi-Link RX Duet™ and ACS Multi-Link OTW Duet™ Coronary Stent Systems. |
Guidant Corporation Santa Clara, CA 95052 |
Approval for inclusion of the six-month clinical trial data from the Duet Study in the Instructions for Use (IFU) for the ACS Multi-Link RX and OTW Duet™ Coronary Stent Systems. |
|
P980016/S011 6/15/00 Real-Time |
Medtronic® Model 7271 Gem™ DR |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for modifications to the circuitry of the Medtronic® Model 7271 GEM™ DR Implantable Cardioverter Defibrillator. |
| 30-DAY NOTICES (135 Day Supplement Was Not Required) | |||
| APPLICATION NUMBER & LTR DATE | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | COMMENTS |
|
P860019/S163 6/14/00 |
Quantum Ranger, NC Ranger, Coyote, and Maxxum PTCA Catheters |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Minor modifications to the existing triforming and trifolding manufacturing process used for the Quantum Ranger, NC Ranger, Coyote, and Maxxum PTCA Catheters. |
|
P860057/S013 6/16/00 |
Carpentier-Edwards® PERIMOUNT® Percardial Valve |
Edwards Lifesciences LLC Irvine, CA 92614 |
Change in vendor supplier for the material identified as polyester. |
|
P870056/S013 6/16/00 |
Carpentier-Edwards® Bioprosthesis |
Edwards Lifesciences LLC Irvine, CA 92614 |
Change in vendor supplier for the material identified as polyester. |
|
P870077/S011 6/16/00 |
Carpentier-Edwards® Duraflex™ Bioprosthesis |
Edwards Lifesciences LLC Irvine, CA 92614 |
Change in vendor supplier for the material identified as polyester. |
|
P900056/S045 6/6/00 |
RotaGlide™ |
Boston Scientific Corporation Redmond, WA 98052 |
Changes in the manufacturing process, to remove one of the steps from the release criteria for RotaGlide™ lubricant, to move the packaging inspection and review of the Certificate of Analysis from Boston Scientific Corporation Northwest to Boston Scientific Corporation’s Marina Bay distribution center in Quincy, Massachusetts. |
|
P900056/S046 6/14/00 |
Rotablator Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052 |
Alternate vendor for the brake hypo tubes used in the manufacturing of the Rotablator Rotalink advancer and passivated at the vendor, an additional manufacturing step for the component. |
|
P950034/S015 6/23/00 |
Seprafilm™ Bioresorbable Membrane |
Genzyme Corporation Cambridge, MA 02139 |
Elimination of Annual Lot Stability Testing for Seprafilm™ Bioresorbable Membrane (Seprafilm™). |
|
P950037/S014 6/20/00 |
Actros Family of Pulse Generators |
Biotronik, Inc. Lake Oswego, OR 97035 |
Evaluation of a change to smaller blister packaging in the manufacturing process of all current and future bipolar pulse generator families. |
|
P960004/S012 6/7/00 |
ThinLine II™ FINELINE II™ Pacing Leads |
Guidant Corporation St. Paul, MN 55112 |
Five minor changes made to the ThinLine II™ and FINELINE II™ manufacturing processes. |
|
P970035/S021 6/30/00 |
S660 with Discrete Technology™ Over-The-Wire Coronary Stent System |
Medtronic AVE, Inc. Santa Rosa, CA 95403 |
Change in the forming step from a three-step process to a two-step process. |
|
P980001/S020 6/13/00 |
NIR™ w/SOX™ Premounted Stent Delivery System |
Boston Scientific/Scimed Maple Grove, MN 55311 |
Change in manufacturing process to remove two inspection steps for markerband placement on the NIR™ w/SOX™ premounted Stent Delivery System. |
Summary of PMA Originals & Supplements Approved
Originals: 6
Supplements: 45
Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 35
Total On Hold: 44
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 182
Total Active: 106
Total On Hold: 76
Number Greater Than 180 Days: 4
Summary of All PMA Submissions Received
Originals: 4
Supplements: 44
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 45
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 81.5
FDA Time: 60.4 Days MFR Time: 21.2 Days
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