|
Device | ACS RX ROCKET ACS AVENGER CORONARY DILATATION 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 | S183 |
Date Received | 12/18/1997 |
Decision Date | 05/14/1998 |
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 |
Approval Order Statement Approval for the ACS RX Rocket(TM) and ACS Avenger(TM) Coronary Dilatation Catheters with design modifications and additional balloon sizes for the ACS RX Rocket(TM) Coronary Dilatation Catheter. |