|
Device | ACS TX2000 VP CORONARY DILITATION CATHETER |
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 | S174 |
Date Received | 02/25/1997 |
Decision Date | 06/11/1997 |
Reclassified Date
|
10/08/2010 |
Product Code |
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 A MODIFICATION TO THELABELING OF THE ACS RX COMET(TM) CORONARY DILATATION CATHER AND ACS TX2000(TM) CORONARY DILATATION CATHETER. |