PMA P000015S040
- Device
- Nucleus ABI541 Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- Product code
- MHE
- Decision date
- 2021-06-09
- Generic name
- Implant, auditory brainstem
- Approval order statement
- Approval for labeling changes related to the MRI compatibility.
Current openFDA PMA Record#
- Device
- Nucleus ABI541 Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S040
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2021-06-09
- Decision code
- APPR
- Date received
- 2019-08-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for labeling changes related to the MRI compatibility.