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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.
 
DeviceDRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP030009
Supplement NumberS050
Date Received11/15/2010
Decision Date04/12/2011
Withdrawal Date04/02/2026
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO ALLOW THE REMOVAL OF THE IN-PROCESS FUNCTIONAL TESTING COMPLETED ON THE STENTS OF DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS.
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