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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.
 
DeviceWolverine Coronary Cutting Balloon (Monorail and Over-The-Wire)
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP950020
Supplement NumberS082
Date Received08/04/2017
Decision Date08/31/2017
Product Code NWX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Update the BSC2000-2 cycle conducted in Chamber 2 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software, an additional vacuum pump booster, and a new validation documentation structure used to support the system.
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