|
Device | Livewire TC Steerable Electrophysiology Catheter, Safire Bi-directional Ablation Catheter |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S086 |
Date Received | 01/13/2021 |
Decision Date | 03/12/2021 |
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 minor design changes to a printed circuit board assembly and a change in supplier for the manufacture of the printed circuit board assembly. |