HiResolution Bionic Ear System
FDA premarket approval P960058/S144 · decided 2019-12-23
Approval details
- PMA number
- P960058
- Supplement
- S144
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2019-10-01
- Decision date
- 2019-12-23
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for manufacturing changes for the HiRes Ultra Implant and labeling changes to the Surgeon Manual.
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