HiResolution Bionic Ear System
FDA premarket approval P960058/S156 · decided 2022-09-09
Approval details
- PMA number
- P960058
- Supplement
- S156
- 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
- 2022-08-12
- Decision date
- 2022-09-09
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Facility move at a supplier for manufacture of implant parts used in the assembly of the HiRes Ultra and HiRes Ultra 3D cochlear implants.
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