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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 MONORAIL
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130030
Supplement NumberS031
Date Received10/04/2016
Decision Date02/23/2017
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 changes to the manufacturing process and design of the Distal Outer component of the Monorail stent delivery system.
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