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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.
 
DeviceS660 2.75 WITH DISCRETE TECHNOLOGY OTW CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP970035
Supplement NumberS032
Date Received11/14/2001
Decision Date01/31/2002
Withdrawal Date10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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