PMA P000015S020

Device: Nucleus AB1541 Auditory Brainstem Implant
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S020
Product code: MHE
Decision date: 2017-05-09
Classification: Implant, Auditory Brainstem
Generic name: Implant, auditory brainstem
Approval order statement: Transfer of the Arburg 220S Molding Machine (CP800/CP900 Injection Molding Tool System) from the Lane Cove manufacturing site to the Macquarie manufacturing site.

Current openFDA PMA Record#

Device: Nucleus AB1541 Auditory Brainstem Implant
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S020
Product code: MHE
Generic name: Implant, auditory brainstem
Decision date: 2017-05-09
Decision code: OK30
Date received: 2017-04-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Transfer of the Arburg 220S Molding Machine (CP800/CP900 Injection Molding Tool System) from the Lane Cove manufacturing site to the Macquarie manufacturing site.