HiResolution Bionic Ear System
FDA premarket approval P960058/S139 · decided 2019-07-18
Approval details
- PMA number
- P960058
- Supplement
- S139
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2019-05-06
- Decision date
- 2019-07-18
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for a new headpiece variant, the UHP 3D Plus and associated magnets, 3D Magnet Max and 3D Magnet Plus.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.