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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
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP110013
Supplement NumberS088
Date Received01/16/2018
Decision Date12/14/2018
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 18M-4778
Notice Date 01/28/2019
Advisory Committee Cardiovascular
Clinical Trials NCT00752128
NCT01243749
NCT01334268
NCT01946724
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System. The 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. In addition, the Resolute Integrity Zotarolimus-Eluting Coronary Stent System is indicated for treating de novo chronic total occlusions.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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