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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.
 
DeviceULTRA2 CUTTING BALLOON MONORAIL(MR)
Generic NameCatheter, angioplasty, peripheral, transluminal
Regulation Number870.1250
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP950020
Supplement NumberS012
Date Received11/08/2004
Decision Date03/16/2005
Product Code LIT 
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 INTERVENTIONAL TECHNOLOGIES EUROPE, LTD., DONEGAL, IRELAND AND EBIS IOTRON, LTD., OXON, GREAT BRITAIN.
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