AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S089 · decided 2011-11-17
Approval details
- PMA number
- P960058
- Supplement
- S089
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2011-06-01
- Decision date
- 2011-11-17
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A NEW OFF-THE-EAR SOUND PROCESSOR CALLED NEPTUNE AND ITS ASSOCIATED ACCESSORIES. THE NEPTUNE PROCESSOR, WHEN USED WITH THE NEW AQUAMIC HEADPIECE, IS WATERPROOF. IN ADDITION, A NEW VERSION OF SOUNDWAVE PROFESSIONAL SOFTWARE SUITE (SOUNDWAVE 2.1) IS INCLUDED IN THE SUPPLEMENT.
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