| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | NINJA FX PTCA DILATATION CATHETER |
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| Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
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| Applicant | Cordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014 |
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| PMA Number | P880003 |
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| Supplement Number | S080 |
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| Date Received | 10/07/1999 |
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| Decision Date | 07/07/2000 |
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| Reclassified Date | 10/08/2010 |
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| Product Codes |
LIT LOX |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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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