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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
PMA NumberP880003
Supplement NumberS052
Date Received11/22/1995
Decision Date03/13/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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.