FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

PMA Final Decisions Rendered for December 1998

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.

PMA Original Approvals

APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
P970010 12/23/98	Norian® SRS® Cement	Norian Corporation Cupertino, CA 95014-4166	Indicated for use as an adjunct for fracture stabilization in the treatment of low impact, unstable, metaphyseal distal radius fractures, in cases where early mobilization (cast for 2 weeks, then removable splint for 2-4 weeks) is indicated. Use of SRS alone in highly comminuted fractures is not indicated.
P970053 12/17/98	Nidek EC-5000 Excimer Laser System	Nidek Technologies, Inc. Pasadena, CA 91105	Approval for the Nidek EC-5000 Excimer Laser System. This device is indicated for photorefractive keratectomy (PRK) for the reduction or elimination of mild to moderate myopia in patients with the following three characteristics: 1) In PRK treatments for the reduction or elimination of myopia in the low, moderate, or high ranges (-0.75 Diopters (D) to -13.00D) spherical equivalent (S.E.) at the spectacle plan, uncomplicated by refractive astigmatism (i.e., £ 0.75D in any meridian). 2) In patients who have a stable history of pretreatment myopia, that is a change of £ 0.50D in sphere or cylinder in the 12 months period preceding treatment for correction of myopia £ -7.0D S.E., or a change of £ 1.00D in sphere or cylinder for correction of myopia >-7.0D S.E. 3) In patients who are over 21 years of age.
P980024 12/11/98	PathVysionTM; HER-2 DNA Probe Kit	Vysis, Inc. Downers Grove, IL 60515	Approval for the PathyVysionTM; HER-2 DNA Probe Kit. The PathyVysionTM; HER-2 DNA Probe Kit (PathyVysion Kit) is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded human breast cancer tissue specimen. Results from the PathVysion Kit are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in state II, node-positive breast cancer patients. The PathVysion Kit is further indicated as an aid in predict disease-free and overall survival in patients with stage II, node positive breast cancer treated with adjuvant cyclophosphamide, dosorubicin, and 5-fluorouracil (CAF) chemotherapy.

PMA SUPPLEMENTAL APPROVALS
APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
P780010/S020 12/4/98	Permalens (perfilcon A) Hydrophilic Contact Lenses	CooperVision Scottsville, NY 14546	Approval for a ten (10) year expiration date for the Permalens (perfilcon A) Hydrophilic contact lenses. The device, as modified, will be marketed under the trade name as referenced above with no change in the current indications.
P790027/S061 12/28/98	Silicone Posterior Chamber IOLs, PMMA Anterior Chamber IOLs and PMMA Posterior Chamber IOLS	Bausch & Lomb Surgical Claremont, CA 91711	Approval for use of an alternate sterilization chamber at Griffith MicroScience.
P810046/S187 12/28/98	ACS Coronary Dilatation Catheter	Guidant Corporation Advanced Cardiovascular Systems Temecula, CA 92591-4628	Approval to conduct pyrogen testing of ACS Coronary Dilatation Catheters prior to sterilization by E-beam radiation.
P810046/S193 12/22/98	ACS RX GeminiTM; Coronary Dilatation Catheter	Advanced Cardiovascular Systems, Inc. Santa Clara, CA 95052	Approval for the ACS RX GeminiTM; Coronary Dilatation Catheter.
P830060/S044* 12/8/98	100cm Bipolar Endocardial Lead Models 0014/0015	Guidant Corporation St. Paul, MN 55112-5798	Approval for use of a larger diameter wire helix in the lead's tip electrode, and associated labeling changes.
P850049/S006 12/21/98	Gianturco-Roehm Bird’s NestTM; Vena Cava Filter	Cook, Inc. Bloomington, IN 47402	Approval for a change to the packaging.
P850059/S018 12/28/98	Silicone Posterior Chamber IOLs, PMMA Anterior Chamber IOLs and PMMA Posterior Chamber IOLS	Bausch & Lomb Surgical Claremont, CA 91711	Approval for use of an alternate sterilization chamber at Griffith MicroScience.
P860004/S041* 12/4/98	Medtronic SynchromedTM; Infusion System	Medtronic, Inc. Minneapolis, MN 55440-9087	Approval for modifications to the device: 1) Replacement of the quartz crystal oscillator with a surface mount crystal oscillator with the same electrical operating specifications, 2) Replacement of the ceramic wiring board with a fiberglass printed wiring board, 3)Mounting the antenna/reedswitch assembly directly on the wiring board 4) Replacement of the ceramic chip carrier packaging of the microprocessor and integrated circuit with plastic packages, 5) Attachment of the hybrid printed wiring board to the pump center plate with two sided, acrylic adhesive tape rather than a bracket and plastic cup assembly.
P870013/S010 12/28/98	Silicone Posterior Chamber IOLs, PMMA Anterior Chamber IOLs and PMMA Posterior Chamber IOLS	Bausch & Lomb Surgical Claremont, CA 91711	Approval for use of an alternate sterilization chamber at Griffith MicroScience.
P870045/S040 12/28/98	Silicone Posterior Chamber IOLs, PMMA Anterior Chamber IOLs and PMMA Posterior Chamber IOLS	Bausch & Lomb Surgical Claremont, CA 91711	Approval for use of an alternate sterilization chamber at Griffith MicroScience.
P880003/S075 12/11/98	Cordis Ninja PTCA Dilatation Catheters	Cordis Corporation Miami, FL 33102-5700	Approval for the Cordis Ninja PTCA Balloon Dilatation Catheters. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P890055/S005 12/23/98	Flex Tip Intraspinal Kit, Catalog AP-07008	Arrow International Walpole, MA 02081	Approval for the Flex Tip Plus Intraspinal Catheter Kit, Catalog AP-07008. This Catheter Kit will be used with the model 3000 Implantable Pump with Bolus Safety Valve for intraspinal delivery of preservative free morphine to patients with chronic intractable pain.
P900039/S010* 12/7/98	Collagraft® Strip Bone Graft Matrix	Collagen Corporation Palo Alto, CA 94303	Approval for changes to your manufacturing process. These changes involve 1) moving some of the manufacturing operations currently performed in a Class 100 room to a "controlled" environment that provides the equivalent of a Class 10,000 environment, 2) increasing the "hold" time between the remoisturization and irradiation processes, and 3) eliminating both the protein concentration assay for past homogenate mixing and the LAL pyrogenicity assay, as described in the supplement.
P910019/S004 12/30/98	TEC® Coronary Atherectomy System	Interventional Technologies, Inc. San Diego, CA 92123	Approval for a change to the TEC System Power Pack circuitry involving the replacement of the current analog motor control circuitry (integrated circuit, LM1014N-2) with new digital circuitry (integrated circuit microcontroller, PIC16C711).
P910023/S037* 12/9/98	Cadence® Tiered Therapy Defibrillator System	St. Jude Medical, Inc. Sunnyvale, CA 94086-6527	Approval to use alternate silicone materials in the manufacture of Ventritex implantable defibrillators.
P910031/S019 12/11/98	Endosonics OracleTM; PTCA Catheter	Endosonics Corporation Rancho Cordova, CA 95670	Approval for modifications to the Endosonics Oracle MegaSonics Five-64TM; PTCA Catheter.
P910061/S005 12/28/98	Silicone Posterior Chamber IOLs, PMMA Anterior Chamber IOLs and PMMA Posterior Chamber IOLS	Bausch & Lomb Surgical Claremont, CA 91711	Approval for use of an alternate sterilization chamber at Griffith MicroScience.
P910061/S006* 12/14/98	SOFLENS UV-Absorbing Silicone Posterior Chamber Intraocular Lens Models LI51U and LI61U	Bausch and Lomb Surgical Claremont, CA 91711	Approval for the addition of a tumbling and an alternative extraction process to the manufacture of silicone lenses.
P910077/S025 12/2/98	VENTAK® MINITM; IV Models 1790, 1792, 1793, and 1796; VENTAK® MINITM; III+HE Models 1788 and 1789	Guidant Corporation St. Paul, MN 55112-5798	Approval for VENTAK® MINITM; IV Models 1790, 1792, 1793, and 1796; VENTAK® MINITM; III+HE Models 1788 and 1789; VENTAK® MINITM; Application Software Model 2840 (Version 4.0); and the sensitivity adjustment for VENTAK® MINITM; and MINITM; II ICD systems.
P920004/S008 12/11/98	VasoSeal® ES (Extravascular Security) Device	Datascope Corporation Montvale, NJ 07645	Approval to market a modified version of the VasoSeal® Vascular Hemostasis Device. The device, as modified, will be marketed under the trade name VasoSeal® Extra Security (ES) Device and is indicated for reducing time to hemostasis at the femoral arterial puncture site and in reducing time to ambulation in patients who have undergone diagnostic angiography or interventional procedures.
P920030/S002 12/8/98	PSA2 Immunoassay on Chiron Diagnostics ACS:180 and ACS:Centaur Automated Chemiluminiscence Systems	Chiron Corporation Emeryville, CA 94608	Approval for the addition of a new indication for use. The device, as modified, will be marketed under the trade names ACS:180 PSA2 assay and ACS:Centaur PSA2 assay and is indicated for the following indications for use: as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. Prostatic biopsy is required for the diagnosis of cancer; and as aid in the management of patients with prostate cancer.
P920034/S003 12/14/98	Tripter-X1	Medirex Systems, Corporation Wellesley Hills, MA 02481	1)Contained the final report of postapproval study regarding the possible relationship between extracorporeal shock wave lithotripsy and the onset of hypertension, and 2) requested approval for modifications to the Tripter-X1's labeling to reflect the results of this final report.
P930038/S015 12/11/98	Angio-SealTM; Hemostatic Puncture Closure Device	Kendall Bothell, MA 98021	Approval for modifications to the material used for the anchor component of the device.
P940010/S004 12/23/98	OPTIGUIDE Fiber Optic (DCYL Diffuser Series)	QLT Phototherapeutics, Inc. Washington, D.C. 20004-1109	Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).
P940011/S002 12/23/98	Coherent Lambda Plus PDL1 and PDL2 Photodynamic Lasers	Coherent Medical Group Santa Clara, CA 95051	Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).
P940012/S002 12/23/98	Series 600 Dye Laser Modules (opearting at 630+/-3nm) and Series 800 KTP/532 and KTP/YAG (opearating at 532nm) Surgical Lasers	Laserscope San Jose, CA 95134-2011	Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructed endobronchial nonsmall cell lung cancer (NSCLC).
P940034/S009 12/1/98	Gen-Probe® Amplified Mycobacterium Tuberculosis Direct Test	Gen-Probe, Inc. San Diego, CA 92121-4362	Approval for additional text under Warnings: "Sediments prepared using Alpha-Tec Systems, Inc. NAC-PACTM; XPR-PlusTM; A.F.B. Processing Buffer have been shown to interfere with amplification."
P950022/S004* 12/9/98	TVL® Lead System	St. Jude Medical, Inc. Sunnyvale, CA 94086-6527	Approval to use alternate silicone materials in the manufacture of Ventritex defibrillator leads.
P950029/S001 12/22/98	Brio Model Numbers 112, 212, 220, and 222 Pacemaker Systems	ELA Medical Plymouth, MN 55441	Approval for functional changes to reduce size and update algorithms and features in previously approved Chorus RM Model 7034 and Opus RM Model 4534. The device, as modified, will be marketed under the trade name Brio and is indicated for: The generally accepted patient conditions warranting chronic cardiac pacing which include: 1) Symptomatic paroxysmal or permanent second or third-degree AV block; 2) Symptomatic bilateral bundle branch block; 3) Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conductions disorders; 4) Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and 5) Vaso-vagal syndrome or hypersensitive carotid sinus syndromes. The Brio is also indicated for dual-chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony which include: 1) Various degrees of AV block to maintain the atrial contribution to cardiac output; and 2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.
P960007/S009 12/1/98	TransCyteTM;	Advanced Tissue Sciences La Jolla, CA 92037-1005	Approval that the ATP assay be used in place of the MTT assay as a means of monitoring and predicting product characteristics. The product release criteria of the ATP assay stipulate that production lots of TransCyteTM; will be harvested between incubation days 12 to 16 and must have an ATP value in the range of 0.083 to 0.127 moles per bioreactor to be considered an acceptable lot.
P960040/S007 12/8/98	VENTAK® AVTM; AICDTM; Systems	Guidant Corporation St. Paul, MN 55112-5798	Approval for revisions to the Physician's Manuals of the Ventak® AVTM; AICDTM; Systems.
P960040/S008 12/8/98	VENTAK® AV II/IIITM; DR Family of AICDTM; Systems	Guidant Corporation St. Paul, MN 55112-5798	Approval for Software Application Model 2843 Version 2.7 for use with VENTAK® AV II/IIITM; Systems.
P960043/S010 12/21/98	Prostar® and Techstar® Percutaneous Vascular Surgical (PVS) Systems	Perclose, Inc. Menlo Park, CA 94025	Approval to expand the range of users of the Prostar® and Techstar® PVS Systems to include healthcare professionals other than physicians.
P960043/S013 12/7/98	Techstar and Prostar Percutaneous Vascular Surgical Systems	Perclose, Inc. Menlo Park, CA 94025	Approval for an alternate sterilization facility located at Griffith Micro Science, Inc. 4900 South Gifford Ave., Los Angeles, CA 90058.
P960043/S014 12/21/98	Prostar® XL and Techstar® XL Percutaneous Vascular Surgical (PVS) Systems	Perclose, Inc. Menlo Park, CA 94025	Approval for adding precautions to the Clinical Procedure section of the Instructions for Use regarding suture lumen clamping.
P970003/S012* 12/18/98	NeuroCybernetic Prosthesis (NCP®) System, Model 250 NCP Programming Software Version 4.3	Cyberonics, Inc. Houston, TX 77058	Approval for the Model 250 NCP Programming Software Version 4.3 (for use with Model 100 NCP Pulse Generator Versions B and C).
P970003/S013* 12/18/98	NeuroCybernetic Prosthesis (NCP®) System, Model 250 NCP Programming Software Version 4.3	Cyberonics, Inc. Houston, TX 77058	Approval for the Model 500 NCP Accessory Pack.
P980015/S001* 12/14/98	Sharpx Needle Destruction Unit	Biomedical Disposal, Inc. Washington, D.C. 20006	Approval for the modifications of device and to the labeling. The modifications to the device were noted to include the addition of a charger base and modifications to the device housing, electrode assembly and filter.

*Evaluated as a "Real-Time Review" PMA Supplement.

**A 135 Day Supplement Was Not Required

Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 38

Summary of PMA Originals Under Review
Total Under Review: 67
Total Active: 26
Total On Hold: 41
Number Greater Than 180 Days: 0

Summary of PMA Supplements Under Review
Total Under Review: 202
Total Active: 139
Total On Hold: 63
Number Greater Than 180 Days: 4

Summary of All PMA Submissions Received
Originals: 10
Supplements: 50

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 38
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 120.3
Average Days Fr Filing to Decision (Total Time): 120.3
Average Days Fr Filing to Decision (FDA Time): 97.6
Average Days Fr Filing to Decision (Mfr Time): 22.7

Updated 12/7/2000

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH