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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.
 
DeviceFIRESTAR RX PTCA BALLOON DILATATION CATHETER AND DURASTAR RX PTCA BALLOON DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantCordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP880003
Supplement NumberS098
Date Received07/30/2009
Decision Date08/13/2009
Reclassified Date10/08/2010
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MODIFICATION OF A CAUTION STATEMENT IN THE IFU FO THE DEVICE.
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