HiFocus SlimJ Electrode
FDA premarket approval P960058/S121 · decided 2017-11-14
Approval details
- PMA number
- P960058
- Supplement
- S121
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HiFocus SlimJ Electrode
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2017-05-08
- Decision date
- 2017-11-14
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for the Hires Ultra Implant with HiFocus SlimJ electrode and associated tools.
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