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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.
 
DeviceTHOR PTCA DILATION CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
CORDIS CORP.
14201 n.w. 60th ave.
miami lakes, FL 33014-5700
PMA NumberP880003
Supplement NumberS061
Date Received07/23/1996
Decision Date01/17/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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