PMA P000015S021
- Device
- Nucleus AB1541 Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S021
- Product code
- MHE
- Decision date
- 2017-06-13
- Classification
- Implant, Auditory Brainstem
- Generic name
- Implant, auditory brainstem
- Approval order statement
- Introduction of the new CBO Sprint Cleanroom at the Cochlear Brisbane Operations (CBO) manufacturing site.
Current openFDA PMA Record#
- Device
- Nucleus AB1541 Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S021
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2017-06-13
- Decision code
- OK30
- Date received
- 2017-05-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of the new CBO Sprint Cleanroom at the Cochlear Brisbane Operations (CBO) manufacturing site.