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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.
 
DeviceS660 2.75 WITH DISCRETE TECHNOLOGY OTW CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
PMA NumberP970035
Supplement NumberS032
Date Received11/14/2001
Decision Date01/31/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic ave s660 2. 75 with discrete technology 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 (<=24 mm in length) in native coronary artery or arterial bypass graft conduit with a reference diameter between 2. 2 mm and 2. 9 mm. Long-term outcome (beyond 30 days) for this implant is unknown at present.
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