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PMA Final Decisions Rendered for September 1999 |
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 |
---|---|---|---|
9/28/99 |
KERACOR® 116 Ophthalmic Excimer Laser System (16 Units) |
Bausch & Lomb Surgical Claremont, CA 91711 |
Approval for 16 units of the KERACOR® 116 ophthalmic excimer laser system. This device is indicated for myopic photorefractive keratectomy (PRK) in patients who meet the following criteria: 1) In Photorefractive Keratectomy (PRK) treatments for the reduction or elimination of myopia between -1.50 to -7.00D of sphere and less than or equal to -4.5D of astigmatism. 2) In patients with documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination. 3) In patients who are 18 yrs of age or older. |
9/28/99 |
Medtronic Hancock® II Bioprosthetic Heart Valve, Models T505 and T510 |
Medtronic Cardiac Surgery Minneapolis, MN 55432-3576 |
Approval for the Medtronic Hancock® II Bioprosthetic Heart Valve, Models T505 (odd sizes 21 through 29 mm) and T510 (odd sizes 25 through 33 mm). This device is indicated for the replacement of pathologic or prosthetic aortic and mitral valves. |
9/15/99 |
Defender II Model 9201 Implantable Cardioverter Defibrillator |
ELA Medical, Inc. Plymouth, MN 55441 |
This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; 2) recurrent poorly tolerated, sustained ventricular tachycardia (VT). |
9/13/99 |
Durasphere Injectable Bulking Agent |
Advanced UroScience, Inc. Saint Paul, MN 55110 |
This device is indicated for use in the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). |
9/27/99 |
Diva Platform Implantable Pulse Generators and ProVit III Application Software (Version 3.3.2) |
Vitatron, Inc. Minneapolis, MN 55459 |
Approval for the Diva Platform Implantable Pulse Generators and the ProVit III Application Software (version 3.3.2) including the Diamond II Model 820 Pulse Generator; the Ruby II Model 720 Pulse Generator; the Topaz II Model 520 Pulse Generator; the Jade II Model 220 Pulse Generator; the Vita DDDR Model 810 Pulse Generator; the Vita DDD Model 710 Pulse Generator; the Vita VVIR Model 310 Pulse Generator. |
9/30/99 |
FemSoft® Insert |
Rochester Medical Corporation Stewartville, MN 55976 |
Indicated for the management of stress urinary incontinence in adult females. |
9/30/99 |
SURGIFOAM Absorbable Gelatin Sponge, U.S.P. |
Ethicon, Inc. Somerville, NJ 08876-0151 |
Approval for the SURGIFOAM Absorbable Gelatin Sponge, U.S.P. This device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical. |
9/27/99 |
Cook® MBC PTCA Balloon Dilatation Catheter |
Cook, Inc. Bloomington, IN 47402 |
Approval for the Cook® MBC PTCA Balloon Dilatation Catheter (sizes noted in the enclosure). This device is indicated for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. |
9/28/99 |
Guidant Corporation Menlo Park, CA 94025 |
ANCURE Tube System, ANCURE Bifurcated System, ANCURE Iliac Balloon Catheter |
Approval for the ANCURE Tube and Bifurcated Systems and the ANCURE Iliac Balloon Catheter (9 mm to 14 mm sizes). This device has the following indications for use: The ANCURE Tube System is indicated for the endovascular treatment of infrarenal abdominal aortic aneurysms (AAA) in patients having adequate iliac/femoral access, infrarenal non-aneurysmal | Neck length of at least 15 mm and a diameter of no greater than 26mm, distal segment neck length of 12mm and diameter of no greater than 26mm, and morphology suitable for endovascular repair. The ANCURE Bifurcated System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients having adequate iliac/femoral access, infrarenal non-aneurysmal neck length of at least 15mm and a diameter of no greater than 26mm, distal segment lengths of at least 20mm and diameters no greater than 13.4mm, and morphology suitable for endovascular repair. The ANCURE Iliac Balloon Catheter is indicated for use in securing the attachment systems in the iliac arteries and/or to expand vascular prosthesis limbs of the ANCURE ENDOGRAFT® Vascular Prosthesis. |
9/28/99 |
Medtronic AVE Santa Rosa, CA 95407 |
AneuRx Stent Graft System |
This device is indicated for the endovascular treatment of infra renal abdominal aortic or aorto-iliac aneurysms having: 1) Adequate iliac/femoral access; 2) Infrarenal non-aneurysmal neck length of at least 1 cm at the proximal and distal ends of the aneurysm, and a vessel diameter 10-20% smaller than labeled device diameter; 3) Morphology suitable for endovascular repair; and 4) One of the following: A diameter > 5cm; A diameter of 4-5cm and has increased in size by 0.5cm in the last 6 months; or Twice the diameter of the normal infrarenal aorta. |
PMA SUPPLEMENTAL APPROVALS |
|||
APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
N50510/S090 9/17/99 |
Vitek® 2 Gram Negative Susceptibility Test- Tobramycin |
BioMerieux, Inc. Hazelwood, MI 63042-2320 |
Approval for the addition of the antibiotic tobramycin to the Vitek® 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 and is indicated for use in the Vitek® 2 gram negative susceptibility panel for the susceptibility testing of gram negative isolates to tobramycin in the range of £ 1 to ³ 16 m g/ml. |
N50510/S091 9/23/99 |
Vitek® 2 Gram Negative Susceptibility Test for Ciprofloxacin |
BioMerieux, Inc. Hazelwood, MI 63042-2320 |
Approval for the addition of the antibiotic ciprofloxacin at concentrations of 0.5, 2 and 4 m g/ml to the Vitek® 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 and is indicated for use in Vitek® 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to ciprofloxacin in the range of £ 0.25 to ³ 4 m g/ml. |
P790007/S016 9/29/99 |
Hancock Modified Orifice and Modified Orifice Conduit Aortic Bioprosthesis, Models 250 and 150, and Hancock Modified Orifice II Aortic Bioprostheses, Models 250B, 250C, 250D, and 250E |
Medtronic Heart Valves Santa Ana, CA 92705 |
Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA. |
P790018/S035 9/29/99 |
Medtronic Hall Prosthetic Heart Valve, Models A7700 and M7700, Aortic Valved Conduit Prosthesis, Model C7700, Rotatable Aortic Valved Collagen Impregnated Conduit, Model R7700, Aortic Valved Collagen Impregnated Conduit, Model Z7700 |
Medtronic Heart Valve Santa Ana, CA 92705 |
Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA. |
P820003/S074 9/1/99 |
Model 5388 External Pulse Generator |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for labeling changes for the Model 5388 External Pulse Generator. |
P820018/S073* 9/24/99 |
Version R5.111WE Programmer Software for the Model 9602 Programmer |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Version R5.111WE programmer software for the Model 9602 Programmer. |
P830026/S075 9/24/99 |
Rx5000 Programmer Model 522-12 |
Guidant Corporation St. Paul, MN 55112-5798 |
Approval for a manufacturing site located at Benchmark Electronics, 4065 Theurer Blvd., Winona, MN 55987. |
P830045/S067* 9/24/99 |
Model 3264 Rev A Programmer Software for the Model 3250 APSm Programmer |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Model 3264 rev A programmer software for use with the Model 3250 APSm Programmer. |
P840008/S069* 9/2/99 |
Dornier Compact Delta Lithotripter – Stationary, Mobile and Transportable |
Dornier Medical Systems, Inc. Kennesaw, GA 30144 |
Approval for a change that would allow the option of a rotating x-ray anode in addition to the currently available stationary anode. |
9/24/99 |
SpinalPak Bone Growth Stimulator |
Biolectron, Inc. Hackensack, NJ 07601 |
Approval for SpinalPak Bone Growth Stimulator. The device is indicated as a noninvasive bone growth stimulator for use as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. |
P850029/S002* 9/22/99 |
Abbott ER-EIA Monoclonal |
Abbott Laboratories, Abbott Park, IL 60064-6200 |
Approval for adding "Caution: This Product Contains Natural Dry Rubber" to labeling. |
P850049/S007 9/14/99 |
Gianturco-Roehm Bird’s Nest® Vena Cava Filter |
Cook, Inc. Bloomington, IN 47402-0489 |
Approval to add a Patient Guide booklet to each device shipment. |
P860003/S030 9/7/99 |
THERAKOS UVAR® Photopheresis System using UVADEX® |
THERAKOS Exton, PA 19341 |
Approval for a labeling change to reflect the use of UVADEX®, the sterile liquid formulation of 8-methoxypsoralen (8-mop). |
P870078/S005 9/29/99 |
Hancock I Standard Bioprosthesis Valve, Models 242, 343, 342C, and 342R |
Medtronic Heart Valves Santa Ana, CA 92705 |
Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA. |
P880006/S030* 9/24/99 |
Model 3264 Rev A Programmer Software for the model 3250 APSm Programmer |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Model 3264 rev A programmer software for use with the Model 3250 APSm Programmer. |
P880038/S035* 9/24/99 |
Version R5.111WE Programmer Software for the Model 9602 Programmer |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Version R5.111WE programmer software for the Model 9602 Programmer. |
P880086/S047 9/13/99 |
Polarity Pulse Generator Models 2091K and 2091M/S |
St. Jude Medical Sylmar, CA 91392-9221 |
Approval for the Polarity Pulse Generator Models 2091K and 2091M/S. |
P880086/S068* 9/24/99 |
Model 3264 Rev A Programmer Software for the Model 3250 APSm Programmer |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Model 3264 rev A programmer software for use with the Model 3250 APSm Programmer. |
P890025/S012* 9/29/99 |
TDx/TDxFLx Cyclosporine and Metabolites Whole Blood and TDx/TDxFLx Cyclosporine Monoclonal Blood |
Abbott Laboratories Abbott Park, IL 60064-6200 |
Approval for adding "Caution: This product contains natural dry rubber" to the labeling. |
P890043/S033 9/30/99 |
Simpson Coronary AtheroCath® SCA-EX, GTO®, and BANTAM Atherectomy Catheters |
Guidant Corporation Temecula, CA 92589-9018 |
Approval for a change in the labeling for the Simpson Coronary AtheroCath® SCA-EX, GTO®, and BANTAM Atherectomy Catheters to 1) include clinical data from the Balloon versus Optimal Atherectomy Trial (BOAT) and 2) streamline the remainder of the text. |
P900013/S002* 9/22/99 |
Abbott PgR-EIA Monoclonal |
Abbott Laboratories, 60064-6200 |
Approval for adding "Caution: This Product Contains Natural Dry Rubber" to the labeling. |
P900043/S015 9/14/99 |
CrossFlex LC Balloon Expandable Stent with Over-the-Wire Delivery System |
Cordis Corporation Warren, NJ 07059 |
Approval to market a new stent system. The device is indicated for improving coronary luminal diameter in the following: Patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary arteries (length £ 30 mm) with a reference vessel diameter of 3.0 to 4.0 mm. Long term outcome (beyond 6 months) for this permanent implant is unknown at present. |
P900056/S026 9/16/99 |
RotaGlide Lubricant for use with the Rotablator® Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052-3376 |
Approval for the RotaGlide Lubricant. |
P900070/S025* 9/24/99 |
Version R5.111WE Programmer Software for the Model 9602 Programmer |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Version R5.111WE programmer software for the Model 9602 Programmer. |
P910023/S045* 9/27/99 |
Cadence® Tiered Therapy Defibrillator System |
St. Jude Medical Sunnyvale, CA 94886-6527 |
Approval to implement a minor manufacturing change (increase in the number of Kapton layers between the high voltage capacitors) in the Contour and Angstrom implantable defibrillators. |
9/10/99 |
AIA-PACK PA |
Tosoh Medics, Inc. South San Francisco, CA 94080 |
Approval for the AIA-PACK PA. The device is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA System analyzers. This device is indicated for the measurement of serum PSA in conjunction with Digital Rectal Examination (DRE) as an aid in the detection of prostate cancer (CaP) in men fifty years of age and older. Prostate biopsy is required for the diagnosis of cancer. The device is further indicated for the serial measurement of PSA in human serum to be used as an aid in the management of patients with prostatic cancer. |
P910073/S027* 9/29/99 |
ENDOTAK® DSP, ENTDOTAK® ENDURANCE, ENDOTAK® ENDURANCE Ex, ENDOTAK® ENDURANCE EZ Lead Systems and the Model 6952 Lead Extender |
Guidant Corporation St. Paul, MN 55112-5798 |
Approval for a modified DF-1 terminal of the ENDOTAK® series of Endocardial Defibrillation Leads and the Model 6952 Lead Extender, which consists of a shorter terminal pin, a counter bore in the terminal pin, and a modified coil transition. |
P920015/S016 9/24/99 |
Medtronic® Sprint Leads Models 6932, 6937, 6942, 6943 and 6945 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for adding a caution label to the Medtronic® Sprint Lead Models 6932, 6937, 6942, 6943 and 6945. |
P920023/S009 9/17/99 |
UroLume Endoprosthesis |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for a new manufacturing site located at American Medical Systems, 10700 Bren Road West, Minnetonka, MN. |
P930014/S006 9/20/99 |
AcrySof® Single-Piece Foldable Acrylic Posterior Chamber Intraocular Lens (IOL), Model SA30EL |
Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for the AcrySof® Single-Piece Foldable Acrylic Posterior Chamber IOL, Model SA30EL. |
P940034/S007 9/2/99 |
Gen-Probe® Amplified Mycobacterium Tuberculosis Direct Test |
Gen-Probe, Inc. San Diego, CA 92121-4362 |
Approval for modified stability testing specifications, and a modified quality control procedure for monitoring acceptability of specimen processing reagents. The supplement included a protocol for assessing effectiveness of user controls with rRNA controls and a stability testing protocol using the 15 minute selection time that were specific conditions for postapproval requirements described in the approval order for P940034/S004. |
9/30/99 |
Gen-Probe® Amplified Mycobacterium Tuberculosis Direct (MTD) Test |
Gen-Probe, Inc. San Diego, CA 92121-4362 |
Approval for the in vitro diagnostic detection of Mycobacterium tuberculosis complex rRNA in aciid-fast bacilli (AFB) smear positive and negative concentrated sediments prepared from sputum (induced or expectorated), bronchial specimens (e.g., bronchoalveolar lavages or bronchial aspirates) or tracheal aspirates. The MTD test is intended for use only with specimens from patients showing signs and symptoms consistent with active pulmonary tuberculosis. MTD is to be used as an adjunctive test for evaluating either AFB smear positive or negative sediments prepared using NALC-NaOH digestion-decontamination of respiratory specimens. Patients who are suspected of having pulmonary TB based on clinical evaluation and who have received no antituberculous therapy, less than 7 days of such therapy, or have not received such therapy in the last 12 months may be evaluated with this test. The MTD test should be performed only in laboratories proficient in the culture and identification of M. tuberculosis (Level II or III or extent 3 and 4). The MTD test must be performed in conjunction with mycobacterial culture. |
P950024/S002 9/16/99 |
CapSureEpi® Model 4968 Steroid-Eluting Bipolar Epicardial Pacing Lead |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for a new pacing lead model and is indicated for use with a pulse generator as part of a cardiac pacing system. The lead has application where implantable epicardial atrial or ventricular, single or dual chamber pacing systems are indicated. |
P950029/S007* 9/16/99 |
Brio Cardiac Pacemakers (V5) |
ELA Medical, Inc. Plymouth, MN 55441 |
Approval for the introduction of version 5 of the Brio pacemakers, including the introduction of the dedicated bipolar Model 222. |
P960001/S006 9/20/99 |
DePuy 2 Bone Cement (Fast Set Bone Cement) |
DePuy Orthopaedics, Inc. Warsaw, IN 46581-0988 |
Approval for a change in the bone cement formulation to alter the handling characteristics. |
P960001/S008 9/1/99 |
DePuy 1 and Endurance Bone Cements |
DePuy Orthopaedics, Inc. Warsaw, IN 46581-0988 |
Approval for minor labeling changes: 1) change the package insert labeling for DePuy 1 Bone Cement from multilingual to English only; and 2) change to the package labeling for DePuy 1 and Endurance Bone Cements to remove reference to pack sizes that are approved but not currently marketed. |
P960004/S008 9/27/99 |
ThinLine and FINELINE Endocardial Pacemaker Leads |
Guidant Corporation St. Paul, MN 55112-5798 |
Approval for the alternate manufacturing facility located at Guidant Puerto Rico, No. 12 Road No. 698, Dorado, Puerto Rico 00646 and the alternate sterilization facility located at COSMED of Illinois, 1160 Northpoint Blvd., Waukegan, Illinois 60085. |
P960009/S003* 9/30/99 |
Model 3389 DBS Lead for Medtronic Activa Tremor Control System |
Medtronic, Inc., Neurological Division Minneapolis, MN 55421-1200 |
Approval for the Model 3389 DBS Lead (as an alternative tot he existing Model 3387 DBS Lead) for use in conjunction with the existing Medtronic Activa Tremor Control System. |
P960043/S020 9/16/99 |
Techstar® XL Percutaneous Vascular Surgical (PVS) System |
Perclose, Inc. Redwood City, CA 94063 |
Approval for modifications to the manufacture and quality control of the Techstar® XL PVS System. |
P970004/S005* 9/3/99 |
Medtronic® Interstim® System for Urinary Control (Medtronic® Model 3057 Temporary Test Stimulation Lead) |
Medtronic®, Inc. Minneapolis, MN 55421 |
Approval for an alternate insulation material for the Medtronic® Model 3057 Temporary Test Stimulation Lead. |
P970007/S001* 9/22/99 |
Abbott IMx Tacrolimus II |
Abbott Laboratories, Abbott Park, IL 60064-6200 |
Approval for adding "Caution: This Product Contains Natural Dry Rubbber" to the labeling. |
P970024/S003 9/14/99 |
Angeion Sentinel Implantable Cardioverter/Defibrillator (ICD) System |
Angeion Corporation Minneapolis, MN 55428-1088 |
Approval for removal of patient monitoring for the capacitor part number 200068-106 of the post-approval requirement. |
P970029/S001 9/17/99 |
Eclipse TMR Holmium Laser System |
Eclipse Surgical Technologies Sunnyvale, CA 94089 |
Approval for a proposed post-approval study protocol. In addition, all advertising and promotional materials must include the warning about the use of TMR in a patient with unstable angina, the need for patients to sign a consent form and the requirements that apply to the training of practitioners who may use the device. |
P970031/S009 9/29/99 |
Medtronic Freestyle Aortic Root Bioprosthesis |
Medtronic Heart Valves Santa Ana, CA 92705 |
Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA. |
P970043/S001 9/24/99 |
LADARVision® Excimer Laser System |
Autonomous Technologies Corporation Orlando, FL 32826 |
Approval for the inclusion of labeling claims in the Patient Information Booklet, Physician's Booklet, and System Operation Manual regarding the effectiveness of the eye tracker component of the LADARVision® Excimer Laser System when used for the approved indication. Other requested modifications to the labeling included updates to data tables in the Physician's Booklet, and editorial changes and revised operational procedures in the System Operation Manual. |
P970043/S004* 9/24/99 |
LADAR Vision® Excimer Laser System |
Autonomous Technologies, Corporation Orlando, FL 32826 |
Approval for adding software computer screens to provide precautions when refractive parameters were entered that were outside the approved indications for use. These indications for use remain: PRK for the reduction or elimination of -1.00 to -10.00 D of spherical myopia with or without -1.00 to -4.00 D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50 and -10.00 D SE at the spectacle plane where sphere or cylinder magnitude is at least 1.00 D. |
9/29/99 |
Nidek EC-5000 Excimer Laser System for Photorefractive Keratectomy for Moderate Myopia with Astigmatism |
Nidek Technologies, Inc. Pasadena, CA 91105 |
Approval for the Nidek EC-5000 Excimer Laser System for Photorefractive Keratectomy for Moderate Myopia with Astigmatism. This device is intended for use in: 1) the reduction or elimination of myopia with astigmatism ranging in severity from -1.00 to -8.00 diopters (D), in terms of manifest refraction spherical equivalent (MRSE), with refractive astigmatism ranging in severity from -0.5 to -4.00 D cylinder by manifest refraction; due to cylinder coupling effects on sphere, the lower range of the intended use must be restricted in a step-wise fashion. A nomogram lookup table is provided for specific treatment combinations. 2) patients who have a stable history of both pretreatment myopic astigmatism (i.e., magnitude of change in manifest refraction of £ 0.5D per year in terms of MRSE for at least one year proceeding treatment) and pretreatment astigmatism (i.e., a magnitude of change of £ 0.5D per year in cylinder for at least one year preceding treatment); and 3) patients who are over 21 years of age. |
P970058/S004 9/2/99 |
ImageChecker M1000 |
R2 Technology, Inc. Los Altos, CA 94022 |
Approval for new software that places circle markers around correlated mass markers. |
P970061/S007** 9/17/99 |
SCIMED® RADIUS Coronary Stent |
Scimed Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for the addition of a centerless grinding process to widen trace element nitinol tubing material. |
P980015/S003* 9/17/99 |
Sharpx Needle Destruction Unit |
Biomedical Disposal, Inc. Norcross, GA 30092 |
Approval for a modification of a contraindication statement in the labeling. |
P980023/S002* 9/13/99 |
mycroPhylaxPlus, Phylax XM, and TMS 1000Plus Tachyarrhythmia Monitoring System |
Biotronik, Inc. Lake Oswego, OR 97035-5369 |
Approval for device hardware and software modifications. The devices are indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmias; or recurrent poorly tolerated sustained ventricular tachycardia (VT). |
30-DAY NOTICES | |||
---|---|---|---|
APPLICATION NUMBER & LTR DATE | DEVICE NAME | COMPANY NAME | COMMENTS |
P880091/S017*** 9/2/99 |
STAAR Surgical Elastic UVA PC Intraocular Lens (IOL) |
STAAR Surgical Company, Inc. Monrovia, CA 91016 |
The 30-Day Notice requested that STAAR Surgical Company be permitted to implement a Gentinge Castle Autoclave to sterilize products during the scheduled or unscheduled shutdown of the primary autoclave manufactured by Kuhlman Technologies, Inc. |
P900052/S008*** 9/23/99 |
Port-A-Cath® Epidural Implantable Access System; Port-A-Cath® II Epidural Low Profile Implantable Access System |
The 30-day Notice requested a manufacturing process change for the Port-A-Cath® Epidural Implantable Access System and for the Port-A-Cath® II Epidural Low Profile Implantable Access System. This change would allow the use of an automated turbidometric assay method for determination of pyrogens using the LAL-5000 System with PYROS Software. |
|
P930038/S021*** 9/10/99 |
8F Angio-Seal Hemostatic Puncture Closure Device |
Daig Corporation Minnetonka, MN 55345 |
The 30-Day Notice requested a change from 10 weeks to 24 weeks as the maximum duration time between the molding date of the anchor and the sterilization date of the finished device that includes the anchor. |
P950032/S015*** 9/28/99 |
Apligraft® (Graftskin) |
Organogenesis, Inc. Canton, MA 02021 |
The 30-day Notice requested a manufacturing process change. The requested change will place into the manufacturing process the final 3 production-scale incubators manufactured by Lunaire Corporation (model # CI0641W-6SPL). |
P950034/S013*** 9/3/99 |
Seprafilm® Bioresorbable Membrane |
Genzyme Corporation Cambridge, MA 02139-1562 |
The 30-Day Notice requested a manufacturing process change for Seprafilm® Bioresorbable Membrane. The requested change would allow the use of a new Urania Heat Sealer, Model 3500-P, to seal the foil pouches containing Seprafilm®. |
P960011/S003*** 9/2/99 |
BioLon (1% sodium hyaluronate) For Ophthalmic Surgery |
Bio-Technology General Corporation Iselin, NJ 08830 |
The 30-Day Notice requested a manufacturing process change for BioLon (1% sodium hyaluronate). The requested change describes the installation and qualification of an upgrade to Bio-Technology General Corporation's fermentation process at the Rehovot, Israel facility and the validation of the sodium hyaluronate fermentation process after the upgrade. |
*Real-Time Supplement
**135 Day Supplement
***30 Day Notice (135 Day Supplement Was Not Required)
Summary of PMA Originals & Supplements Approved
Originals: 10
Supplements: 51
Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 44
Total On Hold: 35
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 228
Total Active: 158
Total On Hold: 70
Number Greater Than 180 Days: 0
Summary of All PMA Submissions Received
Originals: 3
Supplements: 64
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 51
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 140
FDA Time: 101 Days MFR Time: 39 Days
Updated 7/23/2001
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