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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 place
santa rosa, CA 95403
PMA NumberP160043
Supplement NumberS013
Date Received02/13/2018
Decision Date01/17/2019
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 to introduce changes to the drug-polymer coating process.
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