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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.
 
DeviceCORDIS TITAN & TITAL XL DILATION CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantCordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP880003
Supplement NumberS071
Date Received07/17/1997
Decision Date08/04/1998
Reclassified Date10/08/2010
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 a new indication for use: the post-delivery expansion of the Palmaz-Schatz(TM) Coronary Stet, with the Titan(TM) and Tita(TM) XL PTCA Dilatation Catheters (3.0 mm, 3.25 mm, 3.5mm, 3.75 mm balloon diamters with 9 mm and 18 mm balloon lengths, and a 4.0 mm balloon diameter with 9 mm balloon length.)
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