PMA P000015S038
- Device
- Nucleus ABI541 Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- Product code
- MHE
- Decision date
- 2019-12-04
- Generic name
- Implant, auditory brainstem
- Approval order statement
- Approval for a manufacturing site for two sound processing units: the CP910 and CP920.
Current openFDA PMA Record#
- Device
- Nucleus ABI541 Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S038
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2019-12-04
- Decision code
- APPR
- Date received
- 2019-06-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site for two sound processing units: the CP910 and CP920.