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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.
 
DeviceCUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)
Generic NameCatheter, angioplasty, peripheral, transluminal
Regulation Number870.1250
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP950020
Supplement NumberS011
Date Received10/19/2004
Decision Date03/08/2005
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 AN ALTERNATE IN-HOUSE STERILIZATION SITE LOCATED IN QUINCY, MASSACHUSETTS.
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