PMA P960016S084
- Device
- Livewire TC Steerable Electrophysiology Catheter and Safire Bi-directional Ablation Catheter
- Applicant
- St Jude Medical
- Product code
- LPB
- Decision date
- 2020-11-02
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Approval for software and cybersecurity updates to the Ampere Ablation Generator.
Current openFDA PMA Record#
- Device
- Livewire TC Steerable Electrophysiology Catheter and Safire Bi-directional Ablation Catheter
- Applicant
- St Jude Medical
- PMA number
- P960016
- Supplement
- S084
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2020-11-02
- Decision code
- APPR
- Date received
- 2020-07-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software and cybersecurity updates to the Ampere Ablation Generator.