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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 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.
Classification Namestent, coronary
Generic Namestent, coronary
parkmore business park west
PMA NumberP970035
Supplement NumberS011
Date Received11/12/1998
Decision Date06/03/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Medtronic AVE S540(TM) Over-The_Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in the treatment of acute or threatened closure during a planned interventional procedure in de novo lesions (length <24 mm) within a native coronary artery or arterial bypass graft conduit with a reference diameter between 2.2 and 2.9mm. Long term outcome (beyond 30 days) for this permanent implant is unknown at present.