Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: PALMAZ BALLOON-EXPANDABLE STENT
• Generic Name: STENT, RENAL
• Applicant: Cordis US Corporation; 14201 NW 60th Ave.; Miami Lakes, FL 33014
• PMA Number: P890017
• Supplement Number: S010
• Date Received: 12/06/2001
• Decision Date: 07/10/2002
• Product Code: NIN
• Docket Number: 02M-0348
• Notice Date: 08/08/2002
• Advisory Committee: Cardiovascular
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE CORDIS PALMAZ BALLOON EXPANDABLE STENT (MODELS P104R, P154R, P204R). THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES FOLLOWING SUBOPTIMAL PERCUTANEOUS RENAL ANGIOPLASTY (PTRA) OF A DE NOVO OR RESTENOTIC LESION (<=22 MM IN LENGTH) LOCATED WITHIN 10 MM OF THE AORTORENAL ARTERY BORDER AND WITH A REFERENCE VESSEL DIAMETER OF >= 4 MM AND <= 8 MM. SUBOPTIMAL PTRA RESULTS ARE DEFINED BY ONE OR MORE OF THE FOLLOWING UNFAVORABLE RESULTS: >= 50% RESIDUAL STENOSIS BY VISUAL ESTIMATE, >= 20 MM HG PEAK TRANSLESIONAL PRESSURE GRADIENT, >= 10 MM HG MEAN TRANSLESIONAL PRESSURE GRADIENT, AND/OR GRADE D DISSECTION (A SPIRAL SHAPED FILLING DEFECT WITHIN THE LUMEN OF THE VESSEL) OR ANY DISSECTION WITH SIGNIFICANT COMPROMISE IN LUMEN FLOW.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling