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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.
 
DeviceMEDTRONIC AVE S660 ZIPPER MX CORONARY STENT SYSTEM AND S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP970035
Supplement NumberS042
Date Received08/23/2002
Decision Date10/02/2002
Withdrawal Date10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC AVE S660 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM AND S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM.
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