PMA P000015S034

Device: Nucleus ABI541 Auditory Brainstem Implant
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S034
Product code: MHE
Decision date: 2019-06-05
Classification: Implant, Auditory Brainstem
Generic name: Implant, auditory brainstem
Approval order statement: Approval order should be issued for new accessories and modifications to the firmware and software of the Nucleus 7 system, as well as a research tool named the Cochlear Research Platform.

Current openFDA PMA Record#

Device: Nucleus ABI541 Auditory Brainstem Implant
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S034
Product code: MHE
Generic name: Implant, auditory brainstem
Decision date: 2019-06-05
Decision code: APPR
Date received: 2018-11-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval order should be issued for new accessories and modifications to the firmware and software of the Nucleus 7 system, as well as a research tool named the Cochlear Research Platform.