|
Device | NINJA PTCA DILATION CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014-5700 |
PMA Number | P880003 |
Supplement Number | S075 |
Date Received | 06/01/1998 |
Decision Date | 12/11/1998 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the Cordis Ninja PTCA Balloon Dilatation Catheters. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis fo rth epurpose of improving myocardial perfusion. |