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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 NumberS105
Date Received12/07/2022
Decision Date03/02/2023
Product Code NIN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to approve an alternate supplier of an equivalent resin used as the middle layer in the tri-layer inner component of your stents delivery system.
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