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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 NameULTRA2 CUTTING BALLOON MONORAIL(MR)
Classification Namecatheter, angioplasty, peripheral, transluminal
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
Regulation Number870.1250
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP950020
Supplement NumberS012
Date Received11/08/2004
Decision Date03/16/2005
Product Code
LIT[ Registered Establishments with LIT ]
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 interventional technologies europe, ltd. , donegal, ireland and ebis iotron, ltd. , oxon, great britain.
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