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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 NumberS019
Date Received01/20/2016
Decision Date04/19/2016
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 a change in colorant used in the distal tip component of the delivery catheter.
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