|
Device | ACS RX SOLARIS 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 | S192 |
Date Received | 06/19/1998 |
Decision Date | 10/16/1998 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the ACS RX SOLARIS(TM) Coronary Dilatation Catheter and a modification to the Instructions for Use for ACS PTCA Catheters. The ACS RX SOLARIS(TM) Coronary Dilatation Catheter is indicated for balloon dilatation of: 1) the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; and 2) a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction. |