|
Device | SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS |
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 | S160 |
Date Received | 11/22/1995 |
Decision Date | 12/28/1995 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS OF THE INFLATION/DEFLATION NOTCH OF THE ABOVE CATHETERS AND CHANGES TO THE GUIDE WIRE EXIT NOTCH AND PROXIMAL ADATPION VISUAL INSPECTIN CRITERIA OF THE RX LIFESTREAM CATHETER |