|
Device | THERAPY ABLATION CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P040014 |
Supplement Number | S004 |
Date Received | 09/05/2006 |
Decision Date | 01/10/2007 |
Product Code |
LPB |
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 1) THE ADDITION OF THERMISTOR TEMPERATURE SENSOR CATHETERS TO THE THERAPY CATHETER MODEL MIX, 2) THE ADDITION OF A 1763-E COMPATIBLE INTERFACE CABLE TO THE 4MM THERMISTOR ABLATION CATHETER, AND 3) THE ADDITION OF THE 1778-E COMPATIBLE INTERFACE CABLE TO THE 8MM THERMISTOR ABLATION CATHETER. |