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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameRESOLUTE INTEGRITY ZOTAROLIMUS_ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP110013
Supplement NumberS049
Date Received12/18/2014
Decision Date04/08/2015
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00726453
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for updates to the instructions for use for both the rapid exchange and over-the-wire delivery systems with the latest available follow-up clinical data from the various studies of the global resolute clinical trial program.
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