LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER ? SAFIRE MODEL
FDA premarket approval P960016/S014 · decided 2006-02-24
Approval details
- PMA number
- P960016
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER ? SAFIRE MODEL
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2005-09-09
- Decision date
- 2006-02-24
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE HANDLE DESIGN, DEFLECTION MECHANISM, DEFLECTION CURVES, MATERIALS, MANUFACTURING PROCESSES, AND PACKAGING.
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