|
Device | FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | ABBOTT VASCULAR DEVICES 400 SAGINAW DR. REDWOOD CITY, CA 94063 |
PMA Number | P910031 |
Supplement Number | S011 |
Date Received | 08/26/1996 |
Decision Date | 04/09/1997 |
Reclassified Date
|
10/08/2011 |
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 THE FOLLOWING: 1) A CHANGE IN THE BALLOON DESIGN FROM A DOUBLE LAYER OF POLYETHYLENE WITH A POLYETHYLENE TEREPHALATE CENTER REGION TO A SINGLE LAYER OF POLYETHYLENE TEREPHALATE; 2) A CHANGE IN CATHETER SHAFT MATERIAL FROM POLYETHYLENE TO NYLON; 3) A CHANGE IN THE INTERNAL SHAFT DESIGN FROM A TWO LUMEN SIDE BY SIDE DESIGN TO A TWO LUMEN COAXIAL DESIGN; 4) A CHANGE IN THE BALLOON/SHAFT BONDING METHOD FROM HEAT SEALING TO A URETHANE ADHESIVE; 5) A CHANGE IN THE BALLOON LENGTHS FROM 25 MM TO 22 MM AND FROM 20 MM TO 18 MM; AND 6) A CHANGE IN THE COLOR OF THE CATHETER SHAFT FROM BLUE TO TEAL. |