PMA P960058S047

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S047
Product code: MCM
Decision date: 2006-04-11
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A REVISION TO THE AURIA BEHIND-THE-EAR SOUND PROCESSOR, WHICH WILL BE MARKETED UNDER THE TRADE NAME AURIA HARMONY. THE REVISION INCORPORATES NEW CIRCUITRY, FIRMWARE, AND COMPONENTS, INCLUDING A NEW DIGITAL SIGNAL PROCESSOR CHIP, INTERNAL TELECOIL, BUILT-IN DIAGNOSTIC LIGHT EMITTING DIODE (LED), IMPROVED AUDIO FRONT END, AND ENHANCED FRF TRANSMITTER.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S047
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2006-04-11
Decision code: APPR
Date received: 2005-10-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A REVISION TO THE AURIA BEHIND-THE-EAR SOUND PROCESSOR, WHICH WILL BE MARKETED UNDER THE TRADE NAME AURIA HARMONY. THE REVISION INCORPORATES NEW CIRCUITRY, FIRMWARE, AND COMPONENTS, INCLUDING A NEW DIGITAL SIGNAL PROCESSOR CHIP, INTERNAL TELECOIL, BUILT-IN DIAGNOSTIC LIGHT EMITTING DIODE (LED), IMPROVED AUDIO FRONT END, AND ENHANCED FRF TRANSMITTER.