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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 DILATATION DEVICE
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
ApplicantBOSTON SCIENTIFIC
PMA NumberP950020
Supplement NumberS044
Date Received06/01/2011
Decision Date06/30/2011
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component.
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