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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.
 
DeviceInnova Vascular Self-Expanding Stent with Delivery System
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBoston Scientific Corporation
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP140028
Supplement NumberS055
Date Received01/30/2020
Decision Date05/05/2020
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of a manufacturing site located at Synergy Health AST, SRL, in Alajuela, Costa Rica to perform contract sterilization.
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