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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 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.
 
DeviceNINJA FX PTCA DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
ApplicantCORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014-5700
PMA NumberP880003
Supplement NumberS080
Date Received10/07/1999
Decision Date07/07/2000
Reclassified Date 10/08/2010
Product Codes LIT LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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