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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 Place
Santa Rosa, CA 95403
PMA NumberP110013
Supplement NumberS005
Date Received07/09/2012
Decision Date02/22/2013
Product Code NIQ 
Docket Number 13M-0343
Notice Date 03/22/2013
Advisory Committee Cardiovascular
Clinical TrialsNCT00726453
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETERS IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITHSYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS OF LENGTH <= 35 MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 2.25 MM TO 4.2 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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