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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 Monorail 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 NumberS044
Date Received11/14/2018
Decision Date12/14/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Reduction in the number of samples used for batch release and annual stability testing for the 4.50 and 5.00 mm stents.
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