HiResolution Bionic Ear System
FDA premarket approval P960058/S164 · decided 2024-03-29
Approval details
- PMA number
- P960058
- Supplement
- S164
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2024-02-29
- Decision date
- 2024-03-29
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- an additional supplier for the Naída CI PowerCel charger and Naída M Battery Charger used with the HiResolution Bionic Ear System, to increase production capacity
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.