Nucleus Auditory Brainstem Implant
FDA premarket approval P000015/S041 · decided 2020-07-02
Approval details
- PMA number
- P000015
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus Auditory Brainstem Implant
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2019-11-13
- Decision date
- 2020-07-02
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for the Kanso 2 Sound Processor and associated accessories, Nucleus 7 for Nucleus 22, SmartNav System including SmartNav App and CP1150S Surgical Processor, and Custom Sound Pro.
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