PMA P000025S131

Device
SONNET 3 (EAS) Audio Processor, MAESTRO 11
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S131
Product code
MCM
Decision date
2025-02-13
Classification
Ear, Nose, Throat
Generic name
Implant, cochlear
Approval order statement
Approval for the SONNET 3 (EAS) Audio Processor and MAESTRO 11.

Current openFDA PMA Record#

Device
SONNET 3 (EAS) Audio Processor, MAESTRO 11
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S131
Product code
MCM
Generic name
Implant, cochlear
Decision date
2025-02-13
Decision code
APPR
Date received
2024-06-28
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the SONNET 3 (EAS) Audio Processor and MAESTRO 11.