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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 NameRAPTOR PTCA DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca dilation catheters
Regulation Number870.5100
ApplicantCORDIS CORPORATION
PMA NumberP880003
Supplement NumberS079
Date Received10/01/1999
Decision Date04/27/2000
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the raptor ptca catheter (balloon diameters ranging from 1. 5 mm to 5. 0 mm with lengths ranging from 10 mm to 35 mm).
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