PMA P000015S028
- Device
- Nucleus Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S028
- Product code
- MHE
- Decision date
- 2018-02-01
- Classification
- Implant, Auditory Brainstem
- Generic name
- Implant, auditory brainstem
- Approval order statement
- Change in inspection criteria to accept brazed chassis parts.
Current openFDA PMA Record#
- Device
- Nucleus Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S028
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2018-02-01
- Decision code
- OK30
- Date received
- 2018-01-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in inspection criteria to accept brazed chassis parts.