LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER WITH UNIVERSAL TEMPERATURE MONITORING
FDA premarket approval P960016/S002 · decided 1999-11-15
Approval details
- PMA number
- P960016
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER WITH UNIVERSAL TEMPERATURE MONITORING
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 1999-05-20
- Decision date
- 1999-11-15
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval for eight new catheters marketed under the trade name Livewire TC(TM) Steerable Electrophysiology Catheter with Universal Temperature Monitoring and the Livewire TC(TM) Steerable Electrophysiology Thermistor Extension Cable. The device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT)
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