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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.
 
DeviceBOSTON SCINTIFIC SCIMED PTCA CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC
One Scimed Place
Maple Grove, MN 55311
PMA NumberP880027
Supplement NumberS060
Date Received07/12/2001
Decision Date07/30/2001
Withdrawal Date 04/13/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION.
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