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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 BALLOON
Classification Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
ApplicantBOSTON SCIENTIFIC
PMA NumberP950020
Supplement NumberS048
Date Received12/14/2011
Decision Date05/09/2012
Product Code
NWX[ Registered Establishments with NWX ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an alternate moisture analyzer.
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