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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.
 
DeviceS660TM WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP970035
Supplement NumberS017
Date Received08/24/1999
Decision Date05/09/2000
Withdrawal Date 10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Medtronic AVE (AVE) S660 with Discrete Technology Over-the-Wire and Rapid Exchange Coronary Stent Systems.
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