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PMA Final Decisions Rendered for November 1996

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 No. & Approval Date	Trade Name	Applicant Name, City, State, & Zip Code	Description of Device and Indication
P920011 11/07/96	Maxim™PFS Model 033-301 Pacing Lead	Telectronics Pacing Systems Englewood, CO 80112	The device is intended for chronic pacing and sensing of the ventricle when used with a compatible pulse generator.
P940040 11/26/96	AMPLICOR® Mycobacterium Tuberculosis Test	Roche Molecular Systems, Inc.	This device is a target amplified in vitro diagnostic test for the qualitative detection of M. tuberculosis complex DNA in concentrated sediments prepared from sputum (induced or expectorate), bronchial specimens including bronchoalveolar lavages or aspirates, or tracheal aspirates. The AMPLICOR MTB Test is intended for use as an adjunctive test for evaluating acid fast bacilli (AFB) smear positive sediments prepared using NALC-NaOH or NaOH digestion-decontamination of respiratory specimens from untreated patients suspected of having tuberculosis. Untreated patients are patients who have: (1) received no antituberculosis therapy, (2) had less than 7 days of therapy, or (3) have not received such therapy in the last twelve months. Only untreated patients may be evaluated with this test. The AMPLICOR MTB Test should only be performed in institutions proficient in the culture and identification of M. tuberculosis (ATS Level II and III or CAP extent 3 and 4. The test should always be performed in conjuncting with mycobacterial culture.
P960004 11/12/96	ThinLine™ Models 430-10 and 432-04 Endocardial Pacing Leads	Intermedics, Inc. Angleton, TX 77515	These devices are indicated for chronic pacing and sensing of the atrium or ventricle when used with a compatible pulse generator.
P960019 11/15/96	LaserVision®/VISX Excimer Laser System Model C for Phototherapeutic Keratectomy (PTK) and Photorefractive Keratectomy (PRK)	LaserVision Centers, Inc. St. Louis, MO 63141	The device is indicated for: 1) PTK in patients with decreased best corrected visual acuity and/or with disabling pain that are the result of superficial corneal epithelial irregularities or stromal scars in the anterior one-third of the cornea. The patients must have failed with alternative treatment options. For safety, the immediate postoperative corneal thickness must not be less than 250 microns. Examples of those conditions that warrant PTK are: a) corneal scars and opacity (from trauma and inactive infections), b) dystrophies (Reis-Buckler's, granular and lattice), c) Thygeson's superficial keratitis, d) irregular corneal surfaces associated with filamentary keratitis and Salzmann's nodular degeneration, e) residual band keratopathy after unsuccessful EDTA treatment, and, f) scars subsequent to previous (not concurrent) pterygium excision. 2)PRK for a 6.0 ablation zone in patients who are myopic and meet all of the following criteria: a) 1.0 to 6.0 diopters (D) of myopia with astigmatism of £ 1.0 diopters; b) refractive change is within ± 0.5 D for one year prior to the laser treatment; and c) 18 years of age or older. The stationary LaserVision®/VISX Excimer Laser System Model C for PRK will only be enabled either through the use of the VisionKey™ Card or the software controls in the device to treat simple myopia (no astigmatism) -1.0 to -6.0 D.

PMA Supplement Approvals

Errata for PMA Original Approvals

Application No. & Approval Date	Trade Name	Applicant Name, City, State, & Zip Code	Description of Device and Indication
P920031 10/02/96	Emit® 2000 Cyclosporine Specific Assay	Behring Diagnostics, Inc. San Jose, CA 95161-9013	The device is indicated for in vitro diagnostic use on the Roche Diagnostics Systems COBAS MIRA, COBAS MIRA S, and COBAS MIRA Plus chemistry systems for the quantitative analysis of cyclosporine (CsA) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients.

Updated 12/12/1996

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(Updated Dec. 20, 1996)