PMA P000015S052
- Device
- Nucleus® Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S052
- Product code
- MHE
- Decision date
- 2023-12-13
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, auditory brainstem
- Approval order statement
- introduction of new manufacturing processes for making battery subcomponents of the CP1000 and CP1100 sound processors
Current openFDA PMA Record#
- Device
- Nucleus® Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S052
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2023-12-13
- Decision code
- OK30
- Date received
- 2023-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of new manufacturing processes for making battery subcomponents of the CP1000 and CP1100 sound processors