CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE
FDA premarket approval P960058/S028 · decided 2002-11-25
Approval details
- PMA number
- P960058
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2002-11-01
- Decision date
- 2002-11-25
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR MINOR CHANGES TO THE HIFOCUS ELECTRODE TO BETTER FACILITATE THE PACKING OF THE COCHLEOSTOMY AND ELECTRODE INSERTION. SPECIFICALLY, THE CHANGES ARE TO MOVE THE OFFSET REGION APPROXIMATELY 3 MM FURTHER AWAY FROM THE CURRENT LOCATION.
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