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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 Onyx Zotarolimus-Eluting Coronary Stent Systems
Generic Namecoronary drug-eluting stent
Applicant
MEDTRONIC VASCULAR
3576 unocal place
santa rosa, CA 95403
PMA NumberP160043
Supplement NumberS024
Date Received04/17/2019
Decision Date10/17/2019
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to automated the stent pre-clean manufacturing processes for the Resolute Integrity and Resolute Onyx Drug Eluting Stents.
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