PMA P000015S033
- Device
- Nucleus Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S033
- Product code
- MHE
- Decision date
- 2018-09-10
- Classification
- Implant, Auditory Brainstem
- Generic name
- Implant, auditory brainstem
- Approval order statement
- New internal electrode supplier for the rechargeable battery assemblies.
Current openFDA PMA Record#
- Device
- Nucleus Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S033
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2018-09-10
- Decision code
- OK30
- Date received
- 2018-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New internal electrode supplier for the rechargeable battery assemblies.