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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP950020
Supplement NumberS014
Date Received10/28/2005
Decision Date09/29/2008
Product Code NWX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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