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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.
 
DeviceTITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantCORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014-5700
PMA NumberP880003
Supplement NumberS068
Date Received05/08/1997
Decision Date11/18/1997
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for an additional marker band on the 10 mm balloon length of the THOR(TM) PTCA Dilatation Catheters.
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