HiResolution Bionic Ear System
FDA premarket approval P960058/S119 · decided 2016-11-29
Approval details
- PMA number
- P960058
- Supplement
- S119
- 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
- 2016-07-22
- Decision date
- 2016-11-29
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for the HiRes Ultra Implant Reusable Tools to be placed by AB into the market.
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