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PMA P130016S039

Device
Nucleus Hybrid Cochlear Implant
Applicant
Cochlear Americas
Product code
PGQ
Decision date
2020-04-02
Generic name
Cochlear implant with combined electrical stimulation and acoustic amplification
Approval order statement
Approval for Remote Check, a clinician-enabled option for the Nucleus Smart App, that allows clinicians to monitor the performance of the associated implant system remotely.

Current openFDA PMA Record#

Device
Nucleus Hybrid Cochlear Implant
Applicant
Cochlear Americas
PMA number
P130016
Supplement
S039
Product code
PGQ
Generic name
Cochlear implant with combined electrical stimulation and acoustic amplification
Decision date
2020-04-02
Decision code
APPR
Date received
2019-07-31
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for Remote Check, a clinician-enabled option for the Nucleus Smart App, that allows clinicians to monitor the performance of the associated implant system remotely.