PMA P000015S024

Device: Nucleus Auditory Brainstem Implant
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S024
Product code: MHE
Decision date: 2017-08-23
Classification: Implant, Auditory Brainstem
Generic name: Implant, auditory brainstem
Approval order statement: Move the manufacturing of the CI500 series Sterile Replacement Magnet and the Non-Magnetic Plug to the Macquarie site where similar manufacturing processes occur.

Current openFDA PMA Record#

Device: Nucleus Auditory Brainstem Implant
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S024
Product code: MHE
Generic name: Implant, auditory brainstem
Decision date: 2017-08-23
Decision code: OK30
Date received: 2017-07-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Move the manufacturing of the CI500 series Sterile Replacement Magnet and the Non-Magnetic Plug to the Macquarie site where similar manufacturing processes occur.