HiResolution Bionic Ear System
FDA premarket approval P960058/S122 · decided 2017-11-14
Approval details
- PMA number
- P960058
- Supplement
- S122
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- Date received
- 2017-06-05
- Decision date
- 2017-11-14
- Days to decision
- 162 days
- Decision code
- APPR
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval order for the Naida CI Q90 Acoustic Earhook (Acoustic Earhook) that is intended for use with the approved Naida CI Q90 Sound Processor.
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