PMA P970051S114

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S114
Product code: MCM
Decision date: 2014-04-14
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR MARKETING AN ACCESSORY, THE AQUA+, FOR USE WITH THE NUCLEUS 5 CP810 AND NUCLEUS 6 CP910/CP920 SOUND PROCESSORS, WHICH ARE CURRENTLY APPROVED FOR USE WITH THE COCHLEAR IMPLANT SYSTEM.

Current openFDA PMA Record#

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S114
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2014-04-14
Decision code: APPR
Date received: 2014-01-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MARKETING AN ACCESSORY, THE AQUA+, FOR USE WITH THE NUCLEUS 5 CP810 AND NUCLEUS 6 CP910/CP920 SOUND PROCESSORS, WHICH ARE CURRENTLY APPROVED FOR USE WITH THE COCHLEAR IMPLANT SYSTEM.