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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 Namepercutaneous transluminal angioplasty catheter
Regulation Number870.5100
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.