NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
FDA premarket approval P000015/S010 · decided 2007-12-31
Approval details
- PMA number
- P000015
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2007-12-03
- Decision date
- 2007-12-31
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR USE OF CUSTOM SOUND 2.0 AND THE FREEDOM SOUND PROCESSOR IN RECIPIENTS OF THE NUCLEUS AUDITORY BRAINSTEM IMPLANT.
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