NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S045 · decided 2007-11-28
Approval details
- PMA number
- P970051
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2007-10-09
- Decision date
- 2007-11-28
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE MODIFICATIONS TO CUSTOM SOUND 2.0 PROGRAMMING SOFTWARE TO PROVIDE SEVERAL ENHANCEMENTS TO IMPROVE THE OVERALL USEABILITY FOR THE AUDIOLOGISTS, AND THE CAPABILITY OF LINKING A FREEDOM SPEECH PROCESSOR TO AN IMPLANT VIA AN IDENTIFIER TO MINIMIZE THE POSSIBILITY OF A RECIPIENT USING THE WRONG PROCESSOR.
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