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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.
 
DeviceFLEXATOME 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 NumberS141
Date Received08/01/2023
Decision Date10/30/2023
Product Code NWX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for modifications to the labeling, minor changes to the physical packaging, and updates to the design documentation.
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