HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S108 · decided 2014-07-29
Approval details
- PMA number
- P960058
- Supplement
- S108
- 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
- 2014-02-14
- Decision date
- 2014-07-29
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE CONCAVE UNIVERSAL HEAD PIECE, A REDESIGNED VERSION OF THE CURRENT UNIVERSAL HEAD PIECE. THE CONCAVE UNIVERSAL HEAD PIECE SUPPORTS BOTH BEHIND THE EARAND BODY WORN SOUND PROCESSORS AND IS INTENDED FOR INCREASE OF WEARING COMFORT FOR THE HIRES90K ADVANTAGE IMPLANT USERS.
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