|
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 | S010 |
Date Received | 07/23/1996 |
Decision Date | 12/02/1996 |
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 MODELS OF THE FACT(TM) AND ARC(TM) BALLOON CORONARY DILATATIN CATHETERS WITH AN ADD'L RADIOPAQUE MARKER |