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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.
 
DeviceSEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP840040
Supplement NumberS050
Date Received09/06/1995
Decision Date10/19/1995
Withdrawal Date01/05/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REVISED LABELING TO ADDRESS OUR PTCA LABELING LETTER OF JAN 7, 1995 AND CHANGE THE CORPORATE NAME ON YOUR LABELING FROM MANSFIELD/BOSTON SCIENTIFIC CORP TO SCIMED/BOSTON SCIENTIFIC CORP
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