LIVEWIRE TC CARDIAC ABLATION SYSTEM-ADDITION OF LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY
FDA premarket approval P960016/S001 · decided 1999-06-18
Approval details
- PMA number
- P960016
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIVEWIRE TC CARDIAC ABLATION SYSTEM-ADDITION OF LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 1999-05-06
- Decision date
- 1999-06-18
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval for four curve versions of the TC(TM) catheter line with increased lateral stability, known as the XLS(TM) series.
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