|
Device | THERAPY CATHETER (NON-IRRIGATED) |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P040014 |
Supplement Number | S022 |
Date Received | 03/03/2014 |
Decision Date | 04/28/2014 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THE FIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR. |