HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE
FDA premarket approval P960058/S117 · decided 2016-07-15
Approval details
- PMA number
- P960058
- Supplement
- S117
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2015-08-03
- Decision date
- 2016-07-15
- Days to decision
- 347 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval Order should be issued for this PMA supplement.
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