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PMA Final Decisions Rendered for July 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.
| PDP ORIGINAL APPROVALS (0 for July 1999) |
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PMA ORIGINAL APPROVALS (2 for July 1999) |
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APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
|
7/2/99 |
STAARVISC™ Sodium Hyaluronate Viscoelastic |
STAAR Surgical Company Monrovia, CA 91016 |
Approval for the STAARVISC™ Sodium Hyaluronate Viscoelastic. This device is indicated for use as a surgical aid in ophthalmic anterior and posterior segment surgery including: 1) Cataract extraction with or without implantation of an intraocular lens; 2) Corneal transplant surgery; 3) Glaucoma filtering surgery; and 4) Secondary lens implantation. STAARVISC™ aids in maintaining a deep anterior chamber during surgery, protecting corneal endothelial and surrounding tissues from touch by instruments or intraocular lenses, inflating the capsular bag after cataract extraction and lubricating surgical instruments. |
|
7/2/99 |
TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System |
TMJ Concepts Camarillo, CA 93012 |
Approval for the TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis. The device is indicated for reconstruction of the temporomandibular joint. Patients should be considered if they have one or more of the following conditions: 1) Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; 2) Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; 3) Failed tissue graft; 4) Failed alloplastic joint reconstruction; 5) Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion. |
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PMA SUPPLEMENTAL APPROVALS (31 for July 1999) |
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APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
|
N50510/S085 7/9/99 |
VITEK® 2 System |
BioMerieux Vitek, Inc. Hazelwood, MI 63042-2320 |
Approval for the addition of three antibiotics to the Gram Positive Susceptibility Card. The device is intended as laboratory aid in the determination of the in vitro susceptibility of aerobic gram positive bacteria when tested on a Gram Positive Susceptibility Test Card with various antimicrobial agents and concentrations. |
|
N50510/S087 7/9/99 |
VITEK Gram Negative Susceptibility Card- Ampicillin/ Sulbactam |
BioMerieux Vitek, Inc. Hazelwood, MI 63042-2320 |
Approval for the removal of a limitation for the testing of Enterobacter cloacae with the antibiotic ampicillin/ sulbactam. |
|
N50510/S088 7/12/99 |
VITEK Gram Negative Susceptibility Card-ceftriaxone |
BioMerieux, Inc. Hazelwood, MI 63042-2320 |
Approval for the removal of a limitation for the testing of Klebsiella spp. with the antibiotic ceftriaxone. |
|
N50510/S089 7/26/99 |
BioMerieux, Inc. Hazelwood, MI 63042-2320 |
VITEK® Gram Positive Susceptibility Card-oxacillin |
Approval for the addition to the VITEK® Gram Positive Susceptibility Panels, the antibiotic oxacillin at equivalent concentrations of 0.5, 2, and 5 m g/ml. |
|
N80535/S009 7/16/99 |
Absorbo HP-Absorbable Dusting Powder |
National Starch and Chemical Company Bridgewater, NJ 08807-0500 |
Approval for revised labeling. |
|
P790017/S069 7/22/99 |
D114S Over-the-Wire Balloon Dilatation Catheter |
Medtronic AVE , Inc. Santa Rosa, CA 95403 |
Approval for the D114S Over-the-Wire Balloon Dilatation Catheter. 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. |
|
P800068/S001 7/23/99 |
Endotracheal Tube Changer with Models JEM 370, 365, 360, 355, 350, 340, 330, and 325 |
Instrumentation Industries, Inc. Bethel Park, PA 15102 |
Approval for the following changes: 1)Changes in manufacturing: a) new vendor for lumen extrusion; b) new vendor for imprinting the ink (reacted with a hardener) onto the tube changer; and c) eight additional sizes and three additional colors. 2) Change in labeling: a) change in the indications for use statement to reflect the eight new models; and b) revisions in the instructions for use. |
|
P810002/S049 7/28/99 |
St. Jude Medical Mechanical Heart Valve, Master Series Coated Aortic Valved Graft Model CAVGJ-514 |
St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for the SJM® Master Series Aortic Valved Graft with Meadox® Hemashield® Woven Double Velour Graft, Model CAVGJ-514, in sizes 19, 21, 23, 25, 27, 29, 31, and 33 mm. This device is indicated for use when the aortic valve and the ascending aorta must be replaced. |
|
P820012/S006 7/29/99 |
COSMAN ICP Tele-Sensor® |
Radionics, Inc. Burlington, MA 01803 |
Approval for the addition of a polypropylene connector to the ventricular catheter side of the Tele-Sensor®. |
|
P820075/S009 7/16/99 |
Lamicel Osmotic Cervical Dilator |
Xomed Surgical Products, Inc. Jacksonville, FL 32216-0980 |
Approval for a new sterilization facility located at Sterigenics Intl., Inc., 10811 Withers Cove Park Dr., Charlotte, N.C. |
|
P830045/S065* 7/21/99 |
Models 3500/3510 Programmers with Software Model 3303 V1.03 |
St. Jude Medical Sylmar, CA 91342 |
Approval for modifications to the Model 3303 V1.03 programmer software for use with the Models 3500/3510 Programmers. |
|
P830055/S062* 7/22/99 |
LCS Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581-0988 |
Approval for the addition of a polyethylene replacement bearing for metal-backed patella components to the LCS® Total Knee System. |
|
P850022/S012* 7/26/99 |
OrthoPak® Bone Growth Stimulator System |
Biolectron, Inc. Allendale, NJ 07401 |
Approval for addition of a 3x5-inch package insert (to be used as a daily patient reminder of the key elements of OrthoPak unit maintenance) into the case of every shipped OrthoPak® unit. Each card contains the following information: Bioelectron, Inc., 800-524-0677 Call this number for batteries, electrodes, questions or billing inquiries. 1) Change battery every morning. 2) Change electrodes every 3-7 days or when they will not stick to your skin. Make sure your skin is clean and dry before applying new electrodes. |
|
P850079/S031 7/28/99 |
Frequency™ 55 UV and Frequency™ 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear |
CooperVision Scottsville, NY 14546 |
Approval for the Frequency™ 55 UV lens in spherical and toric configuration for extended wear. |
|
P880081/S024 7/2/99 |
Silicone Posterior Chamber Intraocular Lenses (IOLs) |
Allergan, Inc. Irvine, CA 92623-9534 |
Approval for modifications to the labeling for SLM-2/UV intraocular lenses (IOLs) to incorporate recent findings regarding the comparative incidence of posterior capsule opacification and Nd:YAG capsulotomy with silicone IOLs approved under this PMA versus polymethylmethacrylate (PMMA) IOLs. |
|
P880086/S063* 7/21/99 |
Models 3500/3510 Programmers with Software Model 3303 V1.03 |
St. Jude Medical Sylmar, CA 91342 |
Approval for modifications to the Model 3303 V1.03 programmer software for use with the Models 3500/3510 Programmers. |
|
P880086/S064 7/23/99 |
AddVent Pacing System |
St. Jude Medical, Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for an extension of the approved shelf life for the device including pulse generator Models 2060BL and 2060LR (12 to 18 months), and the Model 1368 Single Pass Lead (12 to 24 months). |
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P880086/S066* 7/27/99 |
Affinity Family of Pacemakers |
St. Jude Medical Sylmar, CA 91342 |
Approval for minor modifications to the firmware of the Affinity series of pulse generators. |
|
P930021/S002 7/23/99 |
EMDOGAIN® |
Biora, Inc. Chicago, IL 60610 |
Approval for revised labeling. |
|
P930031/S006 7/21/99 |
Wallstent® TIPS (Transjugular Intrahepatic Portosystemic Shunt) Endoprosthesis |
Schneider (USA), Inc. Boston Scientific Minneapolis, MN 55442-1656 |
Approval for labeling changes and claims for MRI compatibility for the Wallstent® TIPS Endoprosthesis. |
|
P940007/S005 7/30/99 |
CeeOn Model 912 Foldable Intraocular Lens |
Pharmacia & Upjohn Company Kalamazoo, MI 49001-0199 |
Approval for changes to the Warning Section of the lens package insert. Specifically: "When implanting a lens with a smaller optic (less than or equal to 5.5mm), it is recommended that capsulorhexis, with a diameter smaller than the lens optic, be performed. A thorough cortical cleaning before lens insertion is also recommended." |
|
P940022/S011 7/16/99 |
Clarion Multi-Strategy Cochlear Implant (Adult) and Pediatrics |
Advanced Bionics Corporation Sylmar, CA 91342 |
Approval for the modifications to the Device Fitting Software for adults and pediatrics. The device, as modified, will be marketed under the trade name Clarion Multi-Strategy Cochlear Implant (Adult) and (Pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve. |
|
P960001/S004 7/13/99 |
DePuy 3 Bone Cement (Syringeable Cement) |
DePuy Orthopaedics Warsaw, IN 46581-0988 |
Approval for a new bone cement formulation, in order to change the cement's handling characteristics. The device is indicated for the fixation of prostheses to living bone in Orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty. |
|
P960004/S005* 7/1/99 |
FINELINE™ Pacing Lead Models 4450, 4451, 4475, 4476, 4460, 4461, and 4462 |
Intermedics, Inc. Angleton, TX 77515-2523 |
Approval for the ThinLine™ pacing leads under the Guidant FINELINE™ trade name. These devices are indicated for permanent pacing and sensing in the ventricle and/or the atrium when used with a compatible pulse generator. |
|
P960011/S002 7/1/99 |
BioLon™ 1% Sodium Hyaluronate for Ophthalmic Surgery |
BioLon Iselin, NJ 08830 |
Approval for the use of a new packaging suite and for the use of a semi-automatic process for assembly and labeling of the BioLon™ syringes. |
|
P960025/S001 7/16/99 |
Lumbar I/F Cage® with VSP® Spinal System |
DePuy AcroMed, Inc. Cleveland, OH 44115 |
Approval for the packaging and distribution facility located at DePuy AcroMed, Inc., 325 Paramount Drive, Rayhnam, Massachusetts 02767. |
|
P960058/S010 7/16/99 |
Clarion Multi-Strategy Cochlear Implant (Adult) and (Pediatrics) |
Advanced Bionics Corporation Sylmar, CA 91342 |
Approval for the modifications to the Device Fitting Software for adults and pediatrics. The device, as modified, will be marketed under the trade name Clarion Multi-Strategy Cochlear Implant (Adult) and (Pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve. |
|
P970010/S001 7/16/99 |
Norian SRS® Bone Cement |
Norian Corporation Cupertino, CA 95014-4166 |
Approval for the post-approval clinical and animal study protocols that were requested as Conditions of Approval for the PMA. |
|
P980001/S009 7/1/99 |
NIR™ Premounted Stent Systems |
Boston Scientific Corporation Natick, MA 01760-1537 |
Approval for the additional sterilization facility located at Griffith Micro Sciences, Park Industrial De Petit Rechain, Verviers 4800, Belgium. |
|
P980009/S002 7/28/99 |
Magic WALLSTENT Self-Expanding Coronary Stent |
Boston Scientific Plymouth, MN 55442-1656 |
Approval to add an indication for the treatment of saphenous vein grafts. |
|
P980016/S003 7/27/99 |
Model 7229 (GEM™ II VR) Implantable Cardioverter Defibrillator And Model 9964 Application Software |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for the Model 7229 (GEM™ II VR) Implantable Cardioverter Defibrillator and Model 9964 Application Software and the quality assurance test method and specification for screening the GEM™ II VR for premature battery depletion, and the revised L222 integrated circuit. |
| 30-DAY NOTICES (2 for July 1999) | |||
|---|---|---|---|
| APPLICATION NUMBER & LTR DATE | DEVICE NAME | COMPANY NAME | COMMENTS |
|
P820075/S008** 7/9/99 |
LAMICEL® Osmotic Cervical Dilator |
Xomed Surgical Products, Inc. Jacksonville, FL 32216 |
The 30-Day Notice requested a change in the approved sterilization process of e-beam to gamma radiation process. |
|
P980001/S010** 7/22/99 |
NIR ON™ Ranger™ Premounted Stent Delivery System |
Boston Scientific Corporation Natick, MA 01760-1537 |
The 30-Day Notice requested modification of the dimensions of two packaging components (packaging tube and balloon/stent protector) to allow for easier device removal. |
* Evaluated as a "Real-Time Review" PMA Supplement.
**A 135 Day Supplement Was Not Required
Summary of PMA Originals & Supplements Approved
Originals:
2
Supplements: 31
Summary of PMA Originals Under Review
Total Under Review: 87
Total Active: 56
Total On Hold: 31
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 203
Total Active: 140
Total On Hold: 63
Number Greater Than 180 Days: 8
Summary of All PMA Submissions Received
Originals:
10
Supplements: 57
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number
of Approvals: 31
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 130
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