|
Device | NC NINJA PTCA DILATATION CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014-5700 |
PMA Number | P880003 |
Supplement Number | S081 |
Date Received | 10/12/1999 |
Decision Date | 09/21/2000 |
Reclassified Date
|
10/08/2010 |
Product Codes |
LIT LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE NC RAPTOR PTCA CATHETER (BALLOON DIAMETERS RANGING FROM 2.25 MM TO 4.0 MM AND LENGTHS RANGING FROM 10 MM TO 30 MM). THE NC RAPTOR PTCA 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. MODELS WITH THE FOLLOWING BALLOON SIZES (LENGTH X DIAMETER) ARE ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS: 2.25 MM X 10 MM TO 15 MM; 3.0 MM X 20 MM TO 30 MM; AND 4.0 MM X 15 MM TO 30 MM. |