|
Device | THERAPY ABLATION CATHETER AND IBI 1500T CARDIAC ABLATION GENERATOR |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P040014 |
Supplement Number | S003 |
Date Received | 06/12/2006 |
Decision Date | 11/13/2006 |
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 BI-DIRECTIONAL FUNCTIONALITY DESIGN MODIFICATIONS TO THE THERAPY ABLATION CATHETER. |