|
Device | VALOR AND VALOR XL PTCA DILATATION 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 | S062 |
Date Received | 08/21/1996 |
Decision Date | 11/07/1996 |
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 |
Approval Order Statement APPROVAL FOR QUARTER-SIZE BALLOONS ON THE VALOR AND VALOR XL PTCA DILATATION CATHETERS WHICH ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION O F A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPSOE OF IMPROVING MYOCARDIAL PERFUSION |