Premarket Approval (PMA)

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 Name: NINJA FX PTCA DILATATION CATHETER
• Classification Name: catheters, transluminal coronary angioplasty, percutaneous
• Generic Name: percutaneous transluminal angioplasty catheter
• Regulation Number: 870.5100
• Applicant: CORDIS CORPORATION
• PMA Number: P880003
• Supplement Number: S080
• Date Received: 10/07/1999
• Decision Date: 07/07/2000
• Product Code: LOX [ Registered Establishments with LOX ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 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.