HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S082 · decided 2010-03-30
Approval details
- PMA number
- P960058
- Supplement
- S082
- 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
- 2009-08-28
- Decision date
- 2010-03-30
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A NEW VERSION OF FITTING SOFTWARE, CALLED SOUNDWAVE 1.6.
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