HiResolution Bionic Ear System
FDA premarket approval P960058/S162 · decided 2024-01-10
Approval details
- PMA number
- P960058
- Supplement
- S162
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2023-07-14
- Decision date
- 2024-01-10
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- approval of a new sterilizer at the AB Valencia facility and approval of the adoption of the HiFocus Mid-Scala Electrode Insertion Tool Kit and HiFocus Mid-Scala Electrode Insertion Tool into the Implantable Cochlear System (ICS) family of devices.
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