|
Device | THERAPY CARDIAC ABLATION CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P040014 |
Supplement Number | S008 |
Date Received | 09/04/2008 |
Decision Date | 06/17/2009 |
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 SOFTWARE CHANGES IN THE IBI 1500T9 RF GENERATOR WITH SOFTWARE VERSION 1.42. |