PMA P970051S097

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S097
Product code: MCM
Decision date: 2012-11-09
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL TO INTRODUCE A REMOTE CONTROL (CR120) FOR USE WITH THENUCLEUS 5 (MODEL CP810) SOUND PROCESSOR FOR INTRAOPERATIVE USE TO CONDUCT IMPEDANCE AND AUTONRT, MEASUREMENTS THAT ARE COMMONLY USED DURING COCHLEAR IMPLANT SURGERY TO INDICATE THAT THE ELECTRODES ARE FUNCTIONING AND ARE STIMULATING NERVE TISSUE.

Current openFDA PMA Record#

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S097
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2012-11-09
Decision code: APPR
Date received: 2012-09-11
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO INTRODUCE A REMOTE CONTROL (CR120) FOR USE WITH THENUCLEUS 5 (MODEL CP810) SOUND PROCESSOR FOR INTRAOPERATIVE USE TO CONDUCT IMPEDANCE AND AUTONRT, MEASUREMENTS THAT ARE COMMONLY USED DURING COCHLEAR IMPLANT SURGERY TO INDICATE THAT THE ELECTRODES ARE FUNCTIONING AND ARE STIMULATING NERVE TISSUE.