PMA P000015S016

Device: NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S016
Product code: MHE
Decision date: 2017-06-13
Classification: Implant, Auditory Brainstem
Generic name: Implant, auditory brainstem
Approval order statement: Approval for a new CochlearTM CP1000 Nucleus N7 Sound Processor, which is an external component of the Nucleus 24 Cochlear Implant System, the Nucleus Hybrid L24 Implant System, and the Nucleus Auditory Brainstem Implant System.

Current openFDA PMA Record#

Device: NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S016
Product code: MHE
Generic name: Implant, auditory brainstem
Decision date: 2017-06-13
Decision code: APPR
Date received: 2016-10-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new CochlearTM CP1000 Nucleus N7 Sound Processor, which is an external component of the Nucleus 24 Cochlear Implant System, the Nucleus Hybrid L24 Implant System, and the Nucleus Auditory Brainstem Implant System.