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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(TM)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 NumberS021
Date Received11/21/2016
Decision Date04/07/2017
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 manufacturing site located at Synergy Health Ireland, Ltd., IDA Business and Technology Park, Sragh, Tullamore, Co. Offaly, Ireland , for sterilization of the Innova Vascular Self-Expanding Stent System.
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