PMA P000015S017
- Device
- NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S017
- Product code
- MHE
- Decision date
- 2016-12-21
- Classification
- Implant, Auditory Brainstem
- Generic name
- Implant, auditory brainstem
- Approval order statement
- Manufacturing change to increase the inspection tolerance for the thickness of the silicone over the implant coil.
Current openFDA PMA Record#
- Device
- NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S017
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2016-12-21
- Decision code
- OK30
- Date received
- 2016-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change to increase the inspection tolerance for the thickness of the silicone over the implant coil.