|
Device | ACS RX ESPRIT CORONARY DILATION 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 | S190 |
Date Received | 05/21/1998 |
Decision Date | 07/30/1998 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for additional balloon sizes for the ACS Avenger(TM) Coronary dilatation Catheter (quarter sizes within the range of 2.25-3.75 mm for the currently marketed 15mm and 20mm balloon lengths and half sizes in the rang eof 2.5-4.0mm for a 25mm balloon length. |