HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S080 · decided 2010-06-11
Approval details
- PMA number
- P960058
- Supplement
- S080
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2009-03-26
- Decision date
- 2010-06-11
- Days to decision
- 442 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE ADDITION OF A MOISTURE GETTER MATERIAL IN THE HIRES90KL COCHLEAR IMPLANT AS A PREVENTIVE MEASURE IN THE UNLIKELY EVENT OF A HERMETIC FAILURE.
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