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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 CUTTING BALLOON MICROSURGICAL DILATATION DEVICE
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP950020
Supplement NumberS068
Date Received07/31/2014
Decision Date08/29/2014
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO MOVE THE ELECTRICAL DISCHARGE MACHINING (EDM) PROCESS FOR A COMPONENT OF THE BSC FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE TO THE BSC MAPLE GROVE, MINNESOTA FACILITY.
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