PMA P970051S110

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S110
Product code: MCM
Decision date: 2014-05-08
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A CHANGE TO THE ASSEMBLY CONSTRUCTION OF EXTERNAL SWITCHES ON THE CP810 SOUND PROCESSOR WITH THE INTENTION OF IMPROVING INGRESS PROTECTION AND THEREFORE CORROSION RESISTANCE.

Current openFDA PMA Record#

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S110
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2014-05-08
Decision code: APPR
Date received: 2013-06-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO THE ASSEMBLY CONSTRUCTION OF EXTERNAL SWITCHES ON THE CP810 SOUND PROCESSOR WITH THE INTENTION OF IMPROVING INGRESS PROTECTION AND THEREFORE CORROSION RESISTANCE.