PMA P960058S165

Device: HiResolution Bionic Ear System
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S165
Product code: MCM
Decision date: 2025-01-29
Classification: Ear, Nose, Throat
Generic name: Implant, cochlear
Approval order statement: approval for a manufacturing site located at:Advanced Bionics North America Operations CenterAvenida Riba 875Parque Industrial Condesa 21395Mexicali, Baja California Mexico;for assembly of the Naida M and Naida Q sound processors at the semi-finished goods level.

Current openFDA PMA Record#

Device: HiResolution Bionic Ear System
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S165
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2025-01-29
Decision code: APPR
Date received: 2024-05-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at:Advanced Bionics North America Operations CenterAvenida Riba 875Parque Industrial Condesa 21395Mexicali, Baja California Mexico;for assembly of the Naida M and Naida Q sound processors at the semi-finished goods level.