Chorus Sound Processor and SoundWave Professional Suite 3.2/HiResolution Bionic Ear System
FDA premarket approval P960058/S132 · decided 2019-03-12
Approval details
- PMA number
- P960058
- Supplement
- S132
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Chorus Sound Processor and SoundWave Professional Suite 3.2/HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2018-09-13
- Decision date
- 2019-03-12
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for Chorus sound processor and accessories (battery, battery charger, protective case, programming cable) and SoundWave 3.2 fitting software.
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