LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER
FDA premarket approval P960016/S060 · decided 2016-02-18
Approval details
- PMA number
- P960016
- Supplement
- S060
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2015-11-20
- Decision date
- 2016-02-18
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval for software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.
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