PMA P000015
- Device
- Cochlear Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S048
- Product code
- MHE
- Decision date
- 2026-04-30
- Generic name
- Implant, auditory brainstem
- Approval order statement
- manufacturing process changes at Cochlear's supplier for the CP1110 sound processor rechargeable batteries
Current openFDA PMA Record#
- Device
- Cochlear Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S056
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2026-04-30
- Decision code
- OK30
- Date received
- 2026-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing process changes at Cochlear's supplier for the CP1110 sound processor rechargeable batteries