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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 Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin
Generic NameCoronary drug-eluting stent
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP160043
Supplement NumberS078
Date Received02/12/2024
Decision Date03/08/2024
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  
use of additional sterilization chambers at the established sterilization site with a previously qualified and approved sterilization cycle
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