|
Device | RAPTOR 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 | S079 |
Date Received | 10/01/1999 |
Decision Date | 04/27/2000 |
Reclassified Date
|
10/08/2010 |
Product Codes |
LIT LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Raptor PTCA Catheter (balloon diameters ranging from 1.5 mm to 5.0 mm with lengths ranging from 10 mm to 35 mm). |