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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.
 
DeviceS7 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP970035
Supplement NumberS033
Date Received12/26/2001
Decision Date04/24/2002
Withdrawal Date 10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN OPTIONAL MECHANICAL FIXATION STEP TO THE STENT SECUREMENT PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM AND IS INDICATED FOR THE IMPROVEMENT OF CORONARY LUMINAL DIAMETER.
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