AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S090 · decided 2011-09-12
Approval details
- PMA number
- P960058
- Supplement
- S090
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2011-06-09
- Decision date
- 2011-09-12
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCREASE THE THICKNESS TO DIELECTRIC LAYERS OF THE SUBSTRATE AND IS INDICATED TO PROVIDE USEFUL HEARING TO INDIVIDUALS WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS.
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