HiResolution Bionic Ear System
FDA premarket approval P960058/S149 · decided 2020-12-02
Approval details
- PMA number
- P960058
- Supplement
- S149
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2020-05-04
- Decision date
- 2020-12-02
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for the New Sound Processors (Naida CI M30, Naida CI M90, and Sky CI M90), New Headpieces (Slim HP, Slim HP AquaMic, Slim HP Mic, and Slim HP Standard), Target CI, AB Remote, and Accessories (M Battery Small, M Battery Medium, M Battery Large, M Standard Battery, M Waterproof Battery, M Zn-Air Battery Pak, M Acoustic Earhook, M Earhook, M T-Mic, Slim HP Standard Magnet, Slim HP 3D Magnet, M Programming Cable, Slim HP Color Cap, and Slim HP Color Cap large).
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