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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.
 
Trade NameCORDIS PTCA DILATATION CATHETERS AND CORDIS THOR PTCA DILATATION CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca dilation catheters
Regulation Number870.5100
ApplicantCORDIS CORP.
PMA NumberP880003
Supplement NumberS056
Date Received12/27/1995
Decision Date04/23/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional balloon sizes for the thor ptca dilatation catheters. The additional balloon sizes include 2. 75mm, 3. 25mm, and 3. 75mm diameters and 30mm lengths.
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