PMA P960058S087

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S087
Product code: MCM
Decision date: 2010-12-14
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A NEW VERSION OF HEADPIECE, CALLED THE UNIVERSAL HEADPIECE (UHP). THIS CHANGE IS BEING MADE TO PROVIDE A SINGLE HEADPIECE THAT CAN BE USED UNIVERSALLY WITH THE BODY-WORN AND BEHIND-THE-EAR SOUND PROCESSORS AS PART OF A COCHLEAR IMPLANT SYSTEM.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S087
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2010-12-14
Decision code: APPR
Date received: 2010-10-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW VERSION OF HEADPIECE, CALLED THE UNIVERSAL HEADPIECE (UHP). THIS CHANGE IS BEING MADE TO PROVIDE A SINGLE HEADPIECE THAT CAN BE USED UNIVERSALLY WITH THE BODY-WORN AND BEHIND-THE-EAR SOUND PROCESSORS AS PART OF A COCHLEAR IMPLANT SYSTEM.