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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 SYSTEMS
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC IRELAND
PMA NumberP110013
Supplement NumberS004
Date Received06/29/2012
Decision Date07/25/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Removal of a finished device inspection step.
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