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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 – RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S
Generic NameCoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
PMA NumberP160043
Supplement NumberS069
Date Received05/24/2023
Decision Date06/02/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Transfer of component extrusion operations lines 5, 9, and 13 from the Medtronic Santa Rosa site to the Medtronic Danvers site.
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