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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.
 
DeviceEXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Generic NameSTENT, RENAL
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP060006
Supplement NumberS075
Date Received06/15/2016
Decision Date08/11/2016
Product Code NIN 
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 a manufacturing site located at Boston Scientific, 2 Scimed Place, Maple Grove, Minnesota, for stent finishing, inspection, and cleaning.
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