PMA P960016S086

Device: Livewire TC Steerable Electrophysiology Catheter, Safire Bi-directional Ablation Catheter
Applicant: St Jude Medical
PMA number: P960016
Supplement: S086
Product code: LPB
Decision date: 2021-03-12
Generic name: Cardiac ablation percutaneous catheter
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.

Current openFDA PMA Record#

Device: Livewire TC Steerable Electrophysiology Catheter, Safire Bi-directional Ablation Catheter
Applicant: St Jude Medical
PMA number: P960016
Supplement: S086
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2021-03-12
Decision code: APPR
Date received: 2021-01-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.