Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: PALMAZ BALLOON-EXPANDABLE STENT
• Classification Name: stent, coronary
• Generic Name: iliac stent
• Applicant: CORDIS CORP.
• PMA Number: P890017
• Supplement Number: S010
• Date Received: 12/06/2001
• Decision Date: 07/10/2002
• Product Code: MAF [ Registered Establishments with MAF ]
• Docket Number: 02M-0348
• Notice Date: 08/08/2002
• Advisory Committee: Cardiovascular
• Supplement Type: panel track
• Supplement Reason: labeling change - indications
• Expedited Review Granted?: No
• Combination Product: No
• Information About: Labeling, Approval Order, Summary of Safety and Effectiveness

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