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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.
 
DeviceOnyx Frontier Zotarolimus-Eluting Coronary Stent Systems
Generic NameCoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
PMA NumberP160043
Supplement NumberS066
Date Received03/20/2023
Decision Date08/08/2023
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 ProductYes
Approval Order Statement  
Approval for the transfer of component extrusion manufacturing operations for the Onyx Frontier coextrusion balloons and the Onyx Frontier Bumped Inner components used in the manufacture of the Onyx Frontier device
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