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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 NameNC NINJA PTCA DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal angioplasty catheter
Regulation Number870.5100
ApplicantCORDIS CORPORATION
PMA NumberP880003
Supplement NumberS081
Date Received10/12/1999
Decision Date09/21/2000
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the nc raptor ptca catheter (balloon diameters ranging from 2. 25 mm to 4. 0 mm and lengths ranging from 10 mm to 30 mm). The nc raptor ptca catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Models with the following balloon sizes (length x diameter) are also indicated for the post-delivery expansion of balloon expandable stents: 2. 25 mm x 10 mm to 15 mm; 3. 0 mm x 20 mm to 30 mm; and 4. 0 mm x 15 mm to 30 mm.
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