PMA P130016S007

Device: NUCLEUS 24 HYBRID SYSTEM
Applicant: Cochlear Americas
PMA number: P130016
Supplement: S007
Product code: PGQ
Decision date: 2014-09-09
Generic name: Cochlear implant with combined electrical stimulation and acoustic amplification
Approval order statement: APPROVAL FOR CHANGES TO THE FIRMWARE OF THE CP900 SERIES (NUCLEUS 6) SOUND PROCESSOR AND CR200 SERIES REMOTE ASSISTANTS WHICH WILL ALLOW THE USE OF WIRELESS ACCESSORIES.

Current openFDA PMA Record#

Device: NUCLEUS 24 HYBRID SYSTEM
Applicant: Cochlear Americas
PMA number: P130016
Supplement: S007
Product code: PGQ
Generic name: Cochlear implant with combined electrical stimulation and acoustic amplification
Decision date: 2014-09-09
Decision code: APPR
Date received: 2014-06-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE FIRMWARE OF THE CP900 SERIES (NUCLEUS 6) SOUND PROCESSOR AND CR200 SERIES REMOTE ASSISTANTS WHICH WILL ALLOW THE USE OF WIRELESS ACCESSORIES.