PMA P000015S042
- Device
- Nucleus ABI541 Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S042
- Product code
- MHE
- Decision date
- 2019-12-13
- Generic name
- Implant, auditory brainstem
- Approval order statement
- Manufacturing change of the silicone overmoulding used in the CI500 Series Cochlear Implant and the ABI541 Auditory Brainstem Implant.
Current openFDA PMA Record#
- Device
- Nucleus ABI541 Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S042
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2019-12-13
- Decision code
- OK30
- Date received
- 2019-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change of the silicone overmoulding used in the CI500 Series Cochlear Implant and the ABI541 Auditory Brainstem Implant.