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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 NumberS057
Date Received03/16/2020
Decision Date04/13/2020
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Update to the sterilization cycle at the BSC Coventry, Rhode Island facility and the Steris Tullamore, Ireland contract sterilization facility.
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