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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 System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System
Generic Namecoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR
3576 unocal place
santa rosa, CA 95403
PMA NumberP160043
Supplement NumberS055
Date Received09/29/2021
Decision Date05/12/2022
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for changes to the delivery system and marketing under the Onyx Frontier Zotarolimus-Eluting Coronary Stent System trade name.
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