HiResolution Bionic Ear System
FDA premarket approval P960058/S159 · decided 2023-11-17
Approval details
- PMA number
- P960058
- Supplement
- S159
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2023-05-09
- Decision date
- 2023-11-17
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for a new version of fitting software and a new AB remote support app. Based upon the information submitted, the PMA supplement is approved.
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