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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 ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP110013
Supplement NumberS033
Date Received12/23/2013
Decision Date02/03/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
CHANGES TO AUTOMATE SELECT ANALYTICAL TESTING DOCUMENTATION PROCESSES.
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