PMA P960058S132

Device: Chorus Sound Processor and SoundWave Professional Suite 3.2/HiResolution Bionic Ear System
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S132
Product code: MCM
Decision date: 2019-03-12
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: Approval for Chorus sound processor and accessories (battery, battery charger, protective case, programming cable) and SoundWave 3.2 fitting software.

Current openFDA PMA Record#

Device: Chorus Sound Processor and SoundWave Professional Suite 3.2/HiResolution Bionic Ear System
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S132
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2019-03-12
Decision code: APPR
Date received: 2018-09-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for Chorus sound processor and accessories (battery, battery charger, protective case, programming cable) and SoundWave 3.2 fitting software.