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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 MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS
Classification Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP950020
Supplement NumberS014
Date Received10/28/2005
Decision Date09/29/2008
Product Code
NWX[ Registered Establishments with NWX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing sites located at boston scientific corporation, in maple grove, minnesota and plymouth, minnesota for the manufacture of the blade (atherotomes) and mounted balloon/blade subassembly for the device.
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