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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, Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems
Generic NameCoronary drug-eluting stent
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP160043
Supplement NumberS065
Date Received02/21/2023
Decision Date03/23/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Remove the requirement to complete non-stability indicating tests as part of the annual stability studies for the Resolute Onyx and Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems.
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