|
Device | Thermocool Smarttouch Bi-directional Catheter, Thermocool Smarttouch Bi-directional Catheter |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S093 |
Date Received | 02/10/2023 |
Decision Date | 03/10/2023 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Alternate sub-tier supplier for a component on the catheter printed circuit board (PCB). |