Nucleus ABI541 Auditory Brainstem Implant
FDA premarket approval P000015/S038 · decided 2019-12-04
Approval details
- PMA number
- P000015
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus ABI541 Auditory Brainstem Implant
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2019-06-07
- Decision date
- 2019-12-04
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a manufacturing site for two sound processing units: the CP910 and CP920.
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