|
Device | CORDIS PTCA DILATATION CATHETER, TITAN AND TITAN 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 | S057 |
Date Received | 01/16/1996 |
Decision Date | 05/06/1996 |
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 1)TITAN AND TITAN XL PTCA DILATATION CATHETERS WITH 4.5MM AND 5.0MM DIAMETER BALLOONS AVAILABLE IN 20MM LENGTHS; AND 2)A MODIFIED HUB BONDING PROCESS |