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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 NameCUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)
Classification Namecatheter, angioplasty, peripheral, transluminal
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
Regulation Number870.1250
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP950020
Supplement NumberS011
Date Received10/19/2004
Decision Date03/08/2005
Product Code
LIT[ Registered Establishments with LIT ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate in-house sterilization site located in quincy, massachusetts.
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