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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.
 
DeviceREBEL Platinum Chromium Coronary Stent System
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130030
Supplement NumberS075
Date Received12/07/2022
Decision Date03/02/2023
Product Code MAF 
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 the introduction of an alternative resin material (ReZilok Rx 101) supplied by existing BSC-approved supplier Compounding Solutions.
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