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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.
 
DeviceFlextome Coronary Cutting Balloon
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP950020
Supplement NumberS088
Date Received01/09/2018
Decision Date02/08/2018
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  
Move the blade manufacturing processes from the Boston Scientific Maple Grove, Minneapolis manufacturing facility to the Boston Scientific Arden Hills, Minneapolis manufacturing facility for the atherotome microsurgical blades component used on the Flextome Coronary Cutting Balloon.
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