PMA P000015S043
- Device
- Nucleus Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S043
- Product code
- MHE
- Decision date
- 2020-08-13
- Generic name
- Implant, auditory brainstem
- Approval order statement
- Relocation of the subassembly process for the Radial Welded Magnet Assembly, and the addition of new laser welding equipment.
Current openFDA PMA Record#
- Device
- Nucleus Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S043
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2020-08-13
- Decision code
- OK30
- Date received
- 2020-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of the subassembly process for the Radial Welded Magnet Assembly, and the addition of new laser welding equipment.