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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 NumberS080
Date Received10/07/1999
Decision Date07/07/2000
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 ninja(fx) ptca dilatation catheter with the following balloon sizes: 1. 5 mm x 20 mm, 25 mm, and 30 mm; 2. 0 mm x 20 mm, 25 mm, and 30 mm; 2. 25 mm - 4. 0 mm (in 1/4 mm sizes) x 10 mm, 15 mm, 18mm, 20 mm, 25 mm, and 30 mm; 4. 5 mm x 20 mm; and 5. 0 mm x 20 mm. The ninja(fx) ptca dilatatino 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.