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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
Generic NameCoronary drug-eluting stent
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP110013
Supplement NumberS049
Date Received12/18/2014
Decision Date04/08/2015
Withdrawal Date05/14/2026
Product Code NIQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00726453
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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