HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S114 · decided 2015-08-14
Approval details
- PMA number
- P960058
- Supplement
- S114
- 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
- 2015-01-02
- Decision date
- 2015-08-14
- Days to decision
- 224 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR EXPANDING THE NAÍDA CI SOUND PROCESSOR FAMILY, WHICH AREEXTERNAL COMPONENTS OF THE HIRESOLUTION BIONIC EAR SYSTEM, BY ADDING TWO NEW SOUND PROCESSORS (CI Q90 AND CI Q30), NEW VERSIONS OF THE POWERCEL BATTERY, AND A NEW VERSION OF THE SOUNDWAVE PROFESSIONAL SUITE FITTING SOFTWARE.
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