PMA P960058S114

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S114
Product code: MCM
Decision date: 2015-08-14
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR EXPANDING THE NAÍDA CI SOUND PROCESSOR FAMILY, WHICH AREEXTERNAL COMPONENTS OF THE HIRESOLUTION BIONIC EAR SYSTEM, BY ADDING TWO NEW SOUND PROCESSORS (CI Q90 AND CI Q30), NEW VERSIONS OF THE POWERCEL BATTERY, AND A NEW VERSION OF THE SOUNDWAVE PROFESSIONAL SUITE FITTING SOFTWARE.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S114
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2015-08-14
Decision code: APPR
Date received: 2015-01-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR EXPANDING THE NAÍDA CI SOUND PROCESSOR FAMILY, WHICH AREEXTERNAL COMPONENTS OF THE HIRESOLUTION BIONIC EAR SYSTEM, BY ADDING TWO NEW SOUND PROCESSORS (CI Q90 AND CI Q30), NEW VERSIONS OF THE POWERCEL BATTERY, AND A NEW VERSION OF THE SOUNDWAVE PROFESSIONAL SUITE FITTING SOFTWARE.