HiResolution Bionic Ear System
FDA premarket approval P960058/S148 · decided 2020-05-28
Approval details
- PMA number
- P960058
- Supplement
- S148
- 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
- 2020-04-29
- Decision date
- 2020-05-28
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Facility move for the current supplier for manufacturing of the Printed Circuit Board Assemblies (PCBAs) for the Ultra Family of Implants, and the qualification of an alternate supplier to assemble the PCBAs for the Ultra 3D Implants.
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