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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 NumberS014
Date Received04/21/1999
Decision Date11/16/1999
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 (AVE) S670 with Discrete Technology(TM) Over-The Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomiatic ischemic heart disease due to discrete de novo lesions (length <30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 and 4.0 mm. Long term outcome (beyond 14 days) for this permanent implant is unknown at present.