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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 NameNINJA FX PTCA DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal angioplasty catheter
Regulation Number870.5100
ApplicantCORDIS CORPORATION
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.
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