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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
Generic NameCoronary drug-eluting stent
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP160043
Supplement NumberS027
Date Received08/21/2019
Decision Date02/14/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revisions to the labeling that incorporate the results of the RESOLUTE ONYX Core (2.25 mm - 4.0 mm) and REOSLUTE ONYX 2.00 mm Clinical Studies.
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