PMA P000015
- Device
- Cochlear Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S048
- Product code
- MHE
- Decision date
- 2026-09-28
- Generic name
- Implant, auditory brainstem
- Approval order statement
- a change to the joining process in the manufacturing of the NEUF Child Lock component in Cochlear Sound Processors
Current openFDA PMA Record#
- Device
- Cochlear Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S057
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2026-09-28
- Decision code
- OK30
- Date received
- 2026-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the joining process in the manufacturing of the NEUF Child Lock component in Cochlear Sound Processors