PMA P000015S025
- Device
- Necleus Auditory Brainstem Impant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S025
- Product code
- MHE
- Decision date
- 2017-09-05
- Classification
- Implant, Auditory Brainstem
- Generic name
- Implant, auditory brainstem
- Approval order statement
- Introduction of an additional quality control step after the coil and hardball welding operation of the CI500 series implants.
Current openFDA PMA Record#
- Device
- Necleus Auditory Brainstem Impant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S025
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2017-09-05
- Decision code
- OK30
- Date received
- 2017-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an additional quality control step after the coil and hardball welding operation of the CI500 series implants.