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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 NumberS059
Date Received01/27/2016
Decision Date07/22/2016
Withdrawal Date05/14/2026
Product Code NIQ 
Advisory Committee Cardiovascular
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 to update the labeling for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System Instructions for Use (IFU) for both the Rapid Exchange (RX) and Over-The-Wire (OTW) delivery systems to include the most current clinical follow-up data for the Global RESOLUTE Clinical Trial Program and the Resolute Integrity US (RI-US) Primary Enrollment Group (PEG) Post-Approval Study.
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