FDA.reportPublic FDA data

PMA P000015S041

Device
Nucleus Auditory Brainstem Implant
Applicant
Cochlear Americas
Product code
MHE
Decision date
2020-07-02
Generic name
Implant, auditory brainstem
Approval order statement
Approval for the Kanso 2 Sound Processor and associated accessories, Nucleus 7 for Nucleus 22, SmartNav System including SmartNav App and CP1150S Surgical Processor, and Custom Sound Pro.

Current openFDA PMA Record#

Device
Nucleus Auditory Brainstem Implant
Applicant
Cochlear Americas
PMA number
P000015
Supplement
S041
Product code
MHE
Generic name
Implant, auditory brainstem
Decision date
2020-07-02
Decision code
APPR
Date received
2019-11-13
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the Kanso 2 Sound Processor and associated accessories, Nucleus 7 for Nucleus 22, SmartNav System including SmartNav App and CP1150S Surgical Processor, and Custom Sound Pro.