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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 Place
Maple Grove, MN 55311
PMA NumberP150003
Supplement NumberS088
Date Received05/19/2022
Decision Date02/01/2023
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 for removal of the flushing needle accessory, implementation of the dual chamber pouch for the Synergy Megatron device, and labeling changes for the SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System
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