PMA P000015S051
- Device
- Nucleus® 24 Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S051
- Product code
- MHE
- Decision date
- 2023-10-25
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, auditory brainstem
- Approval order statement
- the relocation of the manufacturing for the CP1000, CP1150, and CP1150S sound processing units and externals
Current openFDA PMA Record#
- Device
- Nucleus® 24 Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S051
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2023-10-25
- Decision code
- OK30
- Date received
- 2023-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the relocation of the manufacturing for the CP1000, CP1150, and CP1150S sound processing units and externals