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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 MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
PMA NumberP150003
Supplement NumberS054
Date Received09/03/2019
Decision Date01/22/2021
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new stent design for the 3.50 to 5.00 mm sizes along with modifications to the expansion balloon and manifold.
Post-Approval StudyShow Report Schedule and Study Progress
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