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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
Classification Namecoronary drug-eluting stent
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
ApplicantBOSTON SCIENTIFIC
PMA NumberP950020
Supplement NumberS042
Date Received12/22/2010
Decision Date09/23/2011
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the gel rating specification scale used for resin material acceptance.
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