|
Device | ACS CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS) |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S167 |
Date Received | 07/09/1996 |
Decision Date | 01/08/1997 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ACS CONCORDE(TM) CORONARY DILATATION CATHETER WITH QUARTER SIZE DIAMETERS IN THE 30 MM AND 40 MM BALLOON LENGTHS, A CHANGE IN THE PROXIMAL CATHETER MARKING MATERIAL AND CHANGES TOT HE MANUFACTURING PROCESS. |