HiResolution Bionic Ear System
FDA premarket approval P960058/S165 · decided 2025-01-29
Approval details
- PMA number
- P960058
- Supplement
- S165
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2024-05-22
- Decision date
- 2025-01-29
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- approval for a manufacturing site located at:Advanced Bionics North America Operations CenterAvenida Riba 875Parque Industrial Condesa 21395Mexicali, Baja California Mexico;for assembly of the Naida M and Naida Q sound processors at the semi-finished goods level.
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