PMA P960058S108

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S108
Product code: MCM
Decision date: 2014-07-29
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE CONCAVE UNIVERSAL HEAD PIECE, A REDESIGNED VERSION OF THE CURRENT UNIVERSAL HEAD PIECE. THE CONCAVE UNIVERSAL HEAD PIECE SUPPORTS BOTH BEHIND THE EARAND BODY WORN SOUND PROCESSORS AND IS INTENDED FOR INCREASE OF WEARING COMFORT FOR THE HIRES90K ADVANTAGE IMPLANT USERS.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S108
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2014-07-29
Decision code: APPR
Date received: 2014-02-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CONCAVE UNIVERSAL HEAD PIECE, A REDESIGNED VERSION OF THE CURRENT UNIVERSAL HEAD PIECE. THE CONCAVE UNIVERSAL HEAD PIECE SUPPORTS BOTH BEHIND THE EARAND BODY WORN SOUND PROCESSORS AND IS INTENDED FOR INCREASE OF WEARING COMFORT FOR THE HIRES90K ADVANTAGE IMPLANT USERS.