PMA P970051S143

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S143
Product code: MCM
Decision date: 2016-09-01
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: Approval for a new CochlearTM CP950 Kanso sound processor, which is an external component of both the Nucleus 24 Cochlear Implant System and the Nucleus Hybrid L24 Implant System.

Current openFDA PMA Record#

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S143
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2016-09-01
Decision code: APPR
Date received: 2016-02-08
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a new CochlearTM CP950 Kanso sound processor, which is an external component of both the Nucleus 24 Cochlear Implant System and the Nucleus Hybrid L24 Implant System.