PMA P000025S089

Device: SONNET/SONNET EAS AUDIO PROCESSORS AND MAESTRO 6.0
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S089
Product code: MCM
Decision date: 2017-02-16
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: Approval for the new front end cochlear implant signal processing features (Microphone Directionality and Wind Noise Reduction) in the SONNET and SONNET EAS audio processors and the fitting of these features with the MAESTRO 6.0 software.”

Current openFDA PMA Record#

Device: SONNET/SONNET EAS AUDIO PROCESSORS AND MAESTRO 6.0
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S089
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2017-02-16
Decision code: APPR
Date received: 2016-08-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the new front end cochlear implant signal processing features (Microphone Directionality and Wind Noise Reduction) in the SONNET and SONNET EAS audio processors and the fitting of these features with the MAESTRO 6.0 software.”