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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.
 
DeviceTHOR PTCA DILATION CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantCordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP880003
Supplement NumberS061
Date Received07/23/1996
Decision Date01/17/1997
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFIED INNER BODY MATERIAL, AN OPTIONAL GUIDEWIRE LUMEN COATING, AN OPTIONAL TIP LENGTH, OPTIONAL DUAL MARKER BANDS, AND A SIX-PLEAT BALLOON FOLDING PROCESS ON THE TITAN AND TITAN XL PTCA DILATATION CATHETERS.
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