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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 SHIELD Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System, YNERGY MEGATRON Monorail Everolimu
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corporation
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP150003
Supplement NumberS102
Date Received07/01/2024
Decision Date10/01/2024
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the removal of the polytetrafluoroethylene (PTFE) coating on the delivery system hypotube and the addition of black ink proximal markers
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