PMA P960058S090

Device: AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S090
Product code: MCM
Decision date: 2011-09-12
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCREASE THE THICKNESS TO DIELECTRIC LAYERS OF THE SUBSTRATE AND IS INDICATED TO PROVIDE USEFUL HEARING TO INDIVIDUALS WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS.

Current openFDA PMA Record#

Device: AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S090
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2011-09-12
Decision code: APPR
Date received: 2011-06-09
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCREASE THE THICKNESS TO DIELECTRIC LAYERS OF THE SUBSTRATE AND IS INDICATED TO PROVIDE USEFUL HEARING TO INDIVIDUALS WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS.