PMA P960058S032

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S032
Product code: MCM
Decision date: 2003-12-16
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR AN OPTIONAL ACCESSORY ITEM THAT CAN BE USED WITH THE PLATINUM HEADPIECE AND AURIA HEADPIECE. THIS ITEM, NAMED HEADPIECE SPACER, IS A PASSIVE PIECE OF ELASTOMER INTENDED TO BE PLACED BETWEEN THE HEADPIECE INNER SURFACE AND THE PATIENT'S SCALP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17 YEARS, 11-MONTHS OF AGE).

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S032
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2003-12-16
Decision code: APPR
Date received: 2003-12-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN OPTIONAL ACCESSORY ITEM THAT CAN BE USED WITH THE PLATINUM HEADPIECE AND AURIA HEADPIECE. THIS ITEM, NAMED HEADPIECE SPACER, IS A PASSIVE PIECE OF ELASTOMER INTENDED TO BE PLACED BETWEEN THE HEADPIECE INNER SURFACE AND THE PATIENT'S SCALP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17 YEARS, 11-MONTHS OF AGE).