HiRes Ultra 3D Cochlear Implant
FDA premarket approval P960058/S129 · decided 2018-08-28
Approval details
- PMA number
- P960058
- Supplement
- S129
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HiRes Ultra 3D Cochlear Implant
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2018-03-12
- Decision date
- 2018-08-28
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for the HiRes Ultra 3D Cochlear Implant and associated accessories.
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