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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.
 
DeviceRESOLUTE INTEGRITY OVER-THE-WIRE ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP110013
Supplement NumberS023
Date Received08/02/2013
Decision Date08/29/2013
Withdrawal Date05/14/2026
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
INTRODUCE AN ALTERNATIVE BUILDING FOR THE MANUFACTURE OF THE MICROTRAC OTW DELIVERY SYSTEM WITHIN THE SAME APPROVED MANUFACTURING FACILITY.
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