PMA P000015S036
- Device
- Nucleus Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- Product code
- MHE
- Decision date
- 2019-11-08
- Generic name
- Implant, auditory brainstem
- Approval order statement
- Approval for a design change for the electronic assemblies of the CI512, CI522, CI532 and the ABI541 implants.
Current openFDA PMA Record#
- Device
- Nucleus Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S036
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2019-11-08
- Decision code
- APPR
- Date received
- 2019-05-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change for the electronic assemblies of the CI512, CI522, CI532 and the ABI541 implants.