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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFLEXTOME CUTTING BALLOON
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP950020
Supplement NumberS053
Date Received08/16/2012
Decision Date09/07/2012
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
An alternate supplier for the balloon protector cap component; and minor dimensional changes for the balloon protector cap component.
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