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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 NumberS017
Date Received04/05/2013
Decision Date07/02/2013
Withdrawal Date05/14/2026
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN UPDATED ANNUAL STABILITY PROTOCOL TO BRACKET THE ADDITIONAL 34 MM AND 38 MM LENGTH STENT SIZES.
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