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PMA Final Decisions Rendered for January 1999 |
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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, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| P980035
1/29/99 |
Medtronic.KappaTM 700/600 Series Pacemakers | Medtronic, Inc.
Minneapolis, MN 55432 |
Approval for the Medtronic.KappaTM 700/600 Series Pacemakers, which include; Medtronic.KappaTM KDR 701, 703, 706, 721, 731, 733, 601, 603, & 606; KD 701, 703, and 706; KVDD 701; and KSR 701, 703, and 706 implantable pacemakers with Medtronic.Vision (Model 9953E) Software. These devices are indicated for the following: Rate adaptive pacing in patients who may benefit from increase pacing rates concurrent with increases in activity. Accepted patient conditions warranting chronic cardiac pacing which include: - Symptomatic paroxysmal or permanents second or third-degree AV block; Symptomatic bilateral bundle branch block; Symptomatic paroxysmal or transient sinus node dysfunctions with or without assocated AV conduction disorders; - Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; - Vasovagal syndromes or hypersensitive carotid sinus syndromes. In addition, Medtronic.KappaTM700/600 Series pacemakers are 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: -various degrees of AV block to maintain the atrial contribution to cardiac output; -VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. Medtronic.KappaTM 700/600 Series pacemakers are also indicated for VDD modes in patients having adequate atrial rates and the following indications: Requirements for ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. This includes the presence of complete AV block when atrial contribution is needed for hemodynamic benefit or when pacemaker syndrome has existed or is anticipated. Normal sinus rhythm and normal AV conduction in patients needing ventricular pacing intermittently. |
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| P790002/S020*
1/26/99 |
EBI Bone Healing System– Model 2001 | Electro-Biology, Inc. (EBI)
Parsippany, NJ 07054 |
Approval for the EBI Bone Healing System - Model 2001, indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudoarthroses in the appendicular system. |
| P790027/S062*
1/28/99 |
Polymethylmethacrylate (PMMA) Posterior Chamber Intraocular Lenses (IOLs) | Bausch & Lomb
Claremont, CA 91711 |
Approval for an alternate packaging configuration for the PMMA IOLs, manufactured at Claremont, CA facility. |
| P810046/S196
1/22/99 |
ACS RX Comet VPTM Coronary Dilatation Catheters | Guidant Corporation
Temecula, CA 92591-4628 |
Approval for the implementation of an additional quality control inspection to further ensure that the balloon size designation on the proximal adaptor is correct for the ACS RX Comet VPTM Coronary Dilatation Catheter and the other ACS Coronary Dilatation Catheters listed in the supplement. |
| P830045/S059
1/21/99 |
Model 3303 Software version 1.01 for the APS III Model 3500 Programmer | St. Jude Medical
Sylmar, CA 91342 |
Approval for the Model 3303 Software version 1.01 for use with the APS III Model 3500 Programmer. |
| P850059/S019*
1/28/99 |
PMMA Anterior Chamber IOLs | Bausch & Lomb
Claremont, CA 91711 |
Approval for an alternate packaging configuration for the PMMA IOLs, manufactured at Claremont, CA facility. |
| P860019/S151*
1/11/99 |
SCIMED® COYOTETM Percutaneous Transluminal Coronary Angioplasty | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for the reduction in the rated burst pressure from 16 to 14 atm for all available lengths (20, 30, and 40mm) of the 2.0mm and 2.5mm diameter balloon sizes of the COYOTETM PTCA catheter. |
| P870013/S011*
1/28/99 |
PMMA Anterior Chamber IOLs | Bausch & Lomb
Claremont, CA 91711 |
Approval for an alternate packaging configuration for the PMMA IOLs, manufactured at Claremont, CA facility. |
| P870018/S022*
1/21/99 |
Transmobile version of Lithostar Modularis | Siemens Medical Systems, Inc.
Iselin, NJ 08830 |
Approval for a transportable (between hospitals) Lithostar Modularis. |
| P870049/S028
1/25/99 |
Microscan® Rapid Fluorogenic Panels | Dade Behring, Inc.
West Sacramento, CA 95691 |
Approval for the addition of a limitation to use an alternative method for testing of Proteus mirabilis and Enterobacter spp. with the antibiotic Cefazolin in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels. |
| P880028/S008
1/29/99 |
Dextran HM 32% Hysteroscopic Distention Medium | Abbott Laboratories
Abbott Park, IL 60064 |
Approval for a change in the approved marketed product stability protocol for the Dextran HM 32% to delete 3 and 6 month test stations from the approved stability protocol. |
| P880086/S050
1/22/99 |
Affinity DR Model 5330 L/R and Affinity SR Model 5130 L/R Rate-Adaptive Pulse Generators with AutoCapture | St. Jude Medical
Sylmar, CA 91342 |
Approval for the Affinity DR Model 5330 L/R Dual-Chamber and Affinity SR Model 5130 L/R Single-Chamber Rate-Adaptive Pulse Generators with AutoCapture. The devices, as modified, will be marketed under the trade Affinity DR Model 5330 L/R and Affinity SR Model 5130 L/R and are indicated for rate-adaptive support pacing. |
| P880086/S051
1/21/99 |
Model 3303 Software version 1.01 for the APS III Model 3500 Programmer | St. Jude Medical
Sylmar, CA 91342 |
Approval for the Model 3303 Software version 1.01 for use with the APS III Model 3500 Programmer. |
| P890055/S007
1/11/99 |
Arrow Model 3000-50 Constant Flow Implantable Pump | Arrow International
Walpole, MA 02081 |
Approval for the Arrow Model 3000-50 Constant Flow Implantable Pump for adults for the following indications: 1)the intraspinal delivery of preservative free morphine for patient with intractable chronic pain, 2) the intraspinal delivery of preservative free morphine for the treatment of pain of malignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5fluorouridine (FUDR), heparinized saline, normal saline, and bacteriostatic water. |
| P910073/S025
1/27/99 |
ENDOTAK® ENDURANCE RxTM Endocardial Defibrillation Lead Models 0144, 0145, and 0146 | Guidant CRM
St. Paul, MN 55112-5798 |
Approval for the Models 0144, 0145 and 0146 endocardial defibrillation leads. The device, as modified, will be marketed under the trade name ENDOTAK® ENDURANCE (RxTM) Endocardial Defibrillation Lead and is indicated for use to provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for VENTAK AICD automatic implantable cardioverter defibrillator systems. |
| P910077/S026*
1/20/99 |
Model 6960 Switchable ECG Patient Cable | Guidant Corporation
St. Paul, MN 55112-5789 |
Approval for a switchable ECG cable that allows
the clinician to display and record ECG signals from seven different vectors
(leads) without moving the ECG electrodes that are attached to the patient.
The device, as modified, will be marketed under the trade name Model 6960
Switchable ECG Cable and is indicated for use as an accessory to the Models
2950 and 2901 Programmer/
Recorder/Monitors (PRMs). |
| P940013/S006
1/7/99 |
Precision UVTM (vasurfilcon A) Hydrophilic Contact Lens for Extended Wear (clear and visibility tinted) | Wesley Jessen Corporation
Des Plaines, IL 60018-5903 |
Approval for modifications to the labeling, including an additional indications statement, "Precision UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye"; and modified Note and Warning as stated below: "Warning: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed." |
| P950005/S003
1/26/99 |
Cordis Webster Diagnostic/Ablation Deflectable Tip Catheter | Cordis Webster, Inc.
Baldwin Park, CA 91706 |
Approval for expanded Indications for Use for the 6 Fr and 7 Fr Cordis Webster Diagnostic/Ablation Deflectable Tip Catheters and interface cables. In addition to the previously approved Indications for interruption of accessory AV conduction pathways associated with tachycardia (AVNRT), and creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia, your ablation system is now approved to treat patients with the following Indications for Use: 1) Pediatric Patients (age 4 years or older); 2) Patients with Persistent Junctional Reciprocating Tachycardia (PJRT); and 3) Patients with Mahaim Fibers. |
| P950009/S003
1/19/99 |
AutoPap Primary Screening System | Neopath, Inc.
Redmond, WA 98052 |
Approval for removal of the stage three-alarm unit. The device is to be used only on conventionally prepared Pap smear slides and is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as "high risk." Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director. |
| P950014/S017*
1/25/99 |
Prostatron | EDAP Technomed, Inc.
Norcross, GA 30071 |
Approval for minor changes to the design of the Prostaprobe. |
| P950032/S002
1/6/99 |
Apligraf | Organogenesis, Inc.
Canton, MA 02021 |
Response to conditions of approval cited in May 22, 1998, Approval Order: 1)revisions in karyology, growth rate and morphology testing and 2)Protocol 98-VSU-002, "A Prospective Study to Determine the Longevity of Apligraf Cells on Patients with Venous Ulcers" as well as the cited methods for obtaining documentation of the viral inactivation processes for transferrin. |
| P950032/S004
1/6/99 |
Apligraf | Organogenesis, Inc.
Canton, MA 02021 |
Response to conditions of approval cited in May 22, 1998, Approval Order: 1)revisions in karyology, growth rate and morphology testing and 2)Protocol 98-VSU-002, "A Prospective Study to Determine the Longevity of Apligraf Cells on Patients with Venous Ulcers" as well as the cited methods for obtaining documentation of the viral inactivation processes for transferrin. |
| P950035/S003
1/19/99 |
NeuroControl Freehand System | NeuroControl Corporation
Valley View, OH 44125 |
Approval for a new manufacturing site located at NeuroControl Corporation, 8333 Rockside Road, Valley View, OH. |
| P950037/S006
1/5/99 |
ACTROS+ Pulse Generator | Biotronik, Inc.
Lake Oswego, OR 97035-5369 |
Approval for a name change of the approved ACTROS Pulse Generator family to the ACTROS+ Pulse Generator family. The device, which has not been modified, will be marketed under the trade name ACTROS+ and is indicated for patients exhibiting chronotropic incompetence and who would benefit from increase pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but are not limited to:sick sinus syndrome (i.e., bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial(SA) block, second- and third- degree AV block and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual- chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing. |
| P960040/S010
1/20/99 |
VENTAK® AV I/IITM DDD Family of AICDTM Systems | Guidant Corporation
St. Paul, MN 55112-5798 |
Approval for Software Application Model 2833 Version 3.1 for use with VENTAK® AV I/IITM DDD AICDTM Systems. |
| P960058/S008
1/19/99 |
CLARION® Multi-Strategy Cochlear Implant (for Children) | Advanced Bionics Corporation
Sylmar, CA 91342 |
Approval for expansion of the indication for use of the Advanced Bionics CLARION Multi-Strategy Cochlear Implant to include children 18 months and older. |
| P970003/S014
1/20/99 |
NeuroCybernetic Prosthesis (NCP®) System | Cyberonics, Inc.
Houston, TX 77058 |
Approval for labeling changes being made to the Model 100 NCP Pulse Generator Physician's Manual, the Model 300 NCP Bipolar Lead Physician's Manual, and the Patient's Manual for the NCP System. |
| P970003/S015
1/28/99 |
NeuroCybernetic Prosthesis System | Cyberonics, Inc.
Houston, TX 77058 |
Approval for a new manufacturing site located at Cyberonics, Inc., 16511 Space Center Blvd., Suite 500, Houston, TX. |
| P970020/S007
1/12/99 |
ACS Multi-LinkTM RX Duet and OTW Duet Coronary Stent Systems | Guidant Corporation
Temecula, CA 92591-4628 |
Approval for an alternate sterilization site located at Advanced Cardiovascular Systems, 26531 Ynez Road, Temecular, CA 92591-4628. |
| P970020/S009
1/28/99 |
ACS Multi-LinkTM and ACS Multi-Link DuetTM Coronary Stent Systems | Guidant Corporation
Temecula, CA 92591-4628 |
Approval for implementation of an additional quality control inspection to further ensure that the balloon size designation on the proximal adaptor is correct for the ACS Multi-Link and ACS Multi-Link Duet Coronary Stent Systems listed in the supplement. |
| P970034/S002
1/12/99 |
UV-Absorbing PMMA Posterior Chamber Intraocular Lenses | Ophthalmic Innovations International, Inc.
Claremont, CA 91711 |
Approval for a packaging facility located at 1501 W. 9th Street, Suite D, Upland, CA 91785. |
| P970058/S002
1/16/99 |
ImageChecker M1000 | R2 Technology, Inc.
Los Altos, CA 94022 |
Approval for new software that significantly reduces extraneous marks while providing a modest increase in sensitivity for detecting of masses. |
| P980009/S001
1/27/99 |
Magic WALLSTENT® Endoprosthesis | Schneider (USA), Inc.
Minneapolis, MN 55442 |
Approval for protocol for the post approval study. |
| P980016/S001
1/6/99 |
Medtronic® Model 7271 GEM DR ICD | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for a manufacturing site located at Medtronic, Inc., Med Rel, Road 909, KM 0.4, Barrio Mariana, Humacao, Puerto Rico, 00661. |
| P980016/S002
1/28/99 |
Medtronic® GEMTM II DR Model 7273 Implantable Cardioverter Defibrillator with Medtronic® Model 9964 GEMTM II DR Programmer Application Software | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for the Medtronic® GEMTM II DR Model 7273 Implantable Cardioverter Defibrillator with Medtronic® Model 9964 GEMTM II DR Programmer Application Software. |
*Evaluated as a "Real-Time Review" PMA Supplement.
| 30-DAY NOTICES | |||
|---|---|---|---|
| APPLICATION NUMBER & LTR DATE | DEVICE NAME | COMPANY NAME | COMMENTS |
| P790017/S068**
1/8/99 |
Apollo Rely (addition of larger sizes), Appollo Rely SP Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel Coating and Miniquet Device and Neptune X-Act and Neptune X-Act DUO Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel Coating and Anti Back Bleed Device | Arterial Vascular Engineering, Inc.
Santa Rosa, CA 95403 |
The 30-Day Notice requested to modify the sterilization parameters to address the excessively long Ethylene Oxide residue quarantine times by reducing as exposure minor modifications to the sterilization parameters are also being introduced to improve efficiency and increase flexibility at the contract sterilization facility. |
| P950034/S010**
1/13/99 |
Seprafilm® Bioresorbable Membrane | Genzyme Corporation
Cambridge, MA 02139 |
The 30-Day Notice requested a manufacturing process change for Seprafilm® Bioresorbable Membrane. The requested change would allow processed ethanol to be reused during the precipitation step of the sodium hyaluronate/carboxymethylecellulose (HA/CMC) powder manufacturing process. |
| P960057/S003**
1/14/99 |
ADCON®-L Adhesion Control Barrier Gel | Gliatech, Inc.
Cleveland, OH 44122 |
The 30-Day Notice requested a change in the water temperature, mixing time and mixing speed used in the manufacturing process for the Adcon® -L Adhesion Control Barrier Gel. The proposed modifications are designed to increase the efficiency of the gel manufacturing process. |
| P970003/S017**
1/28/99 |
Cyberonics Prosthesis System | Cyberonics
Webster, TX 77598 |
The 30-Day Notice requested to bring in-house a seam welding process equivalent to processes performed by subcontractors. The welding process involves welding the can bottom half of the Pulse Generator to a can lid. |
| P970020/S008**
1/25/99 |
ACS MULTI-LINK RX and OTW DUET Coronary Stent System | Guidant Corporation
Temecula, CA 92591 |
The 30-day Notice requested the addition of an on-line inspection to the manufacturing process to provide additional assurance of stent security on the delivery system. |
**A 135 Day Supplement Was Not Required
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 34
Summary of PMA Originals Under Review
Total Under Review: 71
Total Active: 27
Total On Hold: 41
Number Greater Than 180 Days: 0
Summary of PMA Supplements Under Review
Total Under Review: 189
Total Active: 107
Total On Hold: 69
Number Greater Than 180 Days: 5
Summary of All PMA Submissions Received
Originals: 7
Supplements: 23
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