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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 SCIENTIFIC SCIMED PTCA CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBoston Scientific
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP880027
Supplement NumberS057
Date Received03/22/2000
Decision Date04/26/2000
Withdrawal Date04/13/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Boston Scientific Ireland Ltd., Galway, Ireland and for a sterilization site located at Isotron Ireland Ltd, County Offaly, Ireland.
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