PMA P000025S112

Device: Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Software
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S112
Product code: MCM
Decision date: 2019-08-22
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: Approval for the SONNET 2 and SONNET 2 EAS audio processors. The SONNET 2 and SONNET 2 EAS audio processors are updates to existing products (SONNET and SONNET EAS).

Current openFDA PMA Record#

Device: Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Software
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S112
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2019-08-22
Decision code: APPR
Date received: 2019-05-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the SONNET 2 and SONNET 2 EAS audio processors. The SONNET 2 and SONNET 2 EAS audio processors are updates to existing products (SONNET and SONNET EAS).