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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 Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coro
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corporation
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP150003
Supplement NumberS109
Date Received03/21/2025
Decision Date04/18/2025
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  
changes in sample sizes and other acceptance sampling criteria in the OQ/PQ protocols for initial and repeat lines of Synergy XD/Megatron Inner Packaging process and for repeat lines of Synergy Dryer, Synergy/Synergy Shield Inner Pack and Secondary Pack processes
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