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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 NumberS046
Date Received10/30/2017
Decision Date12/01/2017
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  
Update the BSC2000-2 cycle conducted in Chamber 5 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software, a replacement vacuum pump with an additional vacuum pump booster, and a new validation documentation structure used to support the system.
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