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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 NameCORONARY FLEXTOME CUTTING BALLON
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
ApplicantMAQUET CARDIOVASCULAR LLC
PMA NumberP950020
Supplement NumberS058
Date Received11/15/2012
Decision Date12/13/2012
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of alternate manufacturing equipment to test for balloon leaks in the device.
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