PMA P000015S045
- Device
- Nucleus Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S045
- Product code
- MHE
- Decision date
- 2020-12-08
- Generic name
- Implant, auditory brainstem
- Approval order statement
- New lower limit for the wireless power test system used for testing the bidirectional wireless link for the CP1000 (Nucleus 7) sound processor.
Current openFDA PMA Record#
- Device
- Nucleus Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S045
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2020-12-08
- Decision code
- OK30
- Date received
- 2020-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New lower limit for the wireless power test system used for testing the bidirectional wireless link for the CP1000 (Nucleus 7) sound processor.