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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 AND TITAN 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 NumberS052
Date Received11/22/1995
Decision Date03/13/1996
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: 1)TITAN AND TITAN XL PTCA DILATATION CATHETERS WITH 3.25MM AND 3.75MM DIAMETER BALLOONS AVAILABLE IN 9MM OR 18MM LENGTHS 2)A MODIFIED HUB BONDING PROCESS 3)A CHANGE IN THE DEVICE NAME FROM TITAN 18 PTCA DILATATION CATHEGTERS TO TITAN PTCA DILATATION CATHETERS 4)ONE SET OF INSTRUCTION FOR USE FOR ALL TITAN AND TITAN XL PTCA DILATATION CATHETERS
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