LIVEWIRE TC CARDIAC ABLATION SYSTEM-CABLE 10X ETO REUSE/RESTERILIZATION, NEW EXTENSION CABLE
FDA premarket approval P960016/S012 · decided 2003-11-21
Approval details
- PMA number
- P960016
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIVEWIRE TC CARDIAC ABLATION SYSTEM-CABLE 10X ETO REUSE/RESTERILIZATION, NEW EXTENSION CABLE
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2003-07-15
- Decision date
- 2003-11-21
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR THE NEW LIVEWIRE TC CATHETER EXTENSION CABLE-STOCKERT, A NEW CABLE WITH THERMOCOUPLE SENSING ONLY FOR USE WITH THE STOCKERT 70 RADIOFREQUENCY CARDIAC ABLATION GENERATOR.
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