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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 NameFLEXTONE CUTTING BALLOON, H7493BM3XXXXX, H749CBO3XXXXX
Classification Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP950020
Supplement NumberS055
Date Received11/15/2012
Decision Date06/28/2013
Product Code
NWX[ Registered Establishments with NWX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for directions for use (dfu) labeling modifications.
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