HiRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S120 · decided 2017-05-17
Approval details
- PMA number
- P960058
- Supplement
- S120
- 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
- 2016-11-23
- Decision date
- 2017-05-17
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for the Sound Wave Professional Suite Software 3. 1, model number CI-6055-011.
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