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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 Co
Generic NameCoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORPORATION
One Scimed Place
Maple Grove, MN 55311
PMA NumberP150003
Supplement NumberS096
Date Received06/29/2023
Decision Date01/19/2024
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval of introduction of the S756 Ethylene Oxide (EtO) sterilization cycle at Synergy Sterilization (M) Sdn Bhd1 located in Kuala Ketil, Malaysia
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