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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namestent, coronary
Generic Namestent, coronary
6500 paseo padre parkway
fremont, CA 94555
PMA NumberP890017
Supplement NumberS010
Date Received12/06/2001
Decision Date07/10/2002
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 02M-0348
Notice Date 08/08/2002
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product 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