HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S109 · decided 2015-04-14
Approval details
- PMA number
- P960058
- Supplement
- S109
- 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
- 2014-04-21
- Decision date
- 2015-04-14
- Days to decision
- 358 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A LABELING/PACKAGING CHANGE TO THE HIRES 90K ADVANTAGE IMPLANT WITH HIFOCUS MID-SCALA ELECTRODE (HFMS) ELECTRODE (MODEL NUMBER CI-1500-04) AND FOR THE INTRODUCTION OF A REUSABLE INSTRUMENT KIT (MODEL NUMBER CI-4508).
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