PMA P970051S151

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S151
Product code: MCM
Decision date: 2017-06-13
Classification: Implant, Cochlear
Generic name: Implant, cochlear
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 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S151
Product code: MCM
Generic name: Implant, cochlear
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.