|
Device | Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P040014 |
Supplement Number | S047 |
Date Received | 10/28/2022 |
Decision Date | 12/16/2022 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for Sterigenics Utah as an alternate EO sterilization vendor for Irvine EP cables. |