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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 & OTW
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130030
Supplement NumberS025
Date Received07/15/2016
Decision Date08/10/2016
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Software change to the platinum chromium alloy (PCA) wetline used for production of uncoated stent components at the Galway, Ireland; Plymouth, Minnesota; and Maple Grove, Minnesota facilities.
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