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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.
 
DeviceSYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chro
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corporation
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP150003
Supplement NumberS086
Date Received05/02/2022
Decision Date05/25/2022
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  
Addition of Galway as an additional manufacturing site for the Synergy XD and Synergy Megatron Manifold components.
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