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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 SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP110013
Supplement NumberS005
Date Received07/17/2012
Decision Date02/22/2013
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 13M-0343
Notice Date 03/22/2013
Advisory Committee Cardiovascular
Clinical Trials NCT00726453
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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, with symptomatic 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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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