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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.
 
DeviceGOLDIE TM AND GOLDIE TM LONGY PTCA CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBoston Scientific
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP880027
Supplement NumberS044
Date Received01/07/1997
Decision Date02/19/1997
Withdrawal Date04/13/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
INCREASE IN RATED BURST PRESSURE FOR THE GOLDIE(TM) AND GOLDIE(TM) LONGY PTCA CATHETERS.
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