HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S076 · decided 2010-09-10
Approval details
- PMA number
- P960058
- Supplement
- S076
- 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
- 2008-12-01
- Decision date
- 2010-09-10
- Days to decision
- 648 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE OFF-THE-EAR-POWER (EOP) ACCESSORIES DESIGNED TO BE USED WITH THE BEHIND-THE-EAR (BTE) EXTERNAL SOUND PROCESSORS AURIA OR HARMONY.
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