|
Device | ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S200 |
Date Received | 01/20/2000 |
Decision Date | 02/16/2000 |
Reclassified Date
|
10/08/2010 |
Product Codes |
DYG LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement A revision to the Instructions for Use booklet for ACS RX SOLARIS and ACS OTW SOLARIS Coronary Dilatation Catheters to include the addition fo the ACS Multi-Link Tristar Stent to the sections pertaining to post-implant stent dilatation. |