PMA P940022S016

Device: MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S016
Product code: MCM
Decision date: 2001-01-12
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR INCORPORATION OF THE SIZE-REDUCED SPEECH PROCESSOR TO BE WORN BEHIND THE EAR, KNOWN AS THE PLATINUM BTE(TM) SOUND PROCESSOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT PLATINUM BTE SOUND PROCESSOR. THE DEVICE IS INDICATED TO RESTORE A LEVEL OF AUDITORY SENSATION TO INDIVIDUALS WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE. ADULTS: 1) 18 YEARS OF AGE OR OLDER 2) PROFOUND, BILATERAL SENSORINEURAL DEAFNESS (>=90DB) 3) POSTLINGUALLY DEAFENED 4) LACK OF BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS.

Current openFDA PMA Record#

Device: MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S016
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2001-01-12
Decision code: APPR
Date received: 2000-11-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR INCORPORATION OF THE SIZE-REDUCED SPEECH PROCESSOR TO BE WORN BEHIND THE EAR, KNOWN AS THE PLATINUM BTE(TM) SOUND PROCESSOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT PLATINUM BTE SOUND PROCESSOR. THE DEVICE IS INDICATED TO RESTORE A LEVEL OF AUDITORY SENSATION TO INDIVIDUALS WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE. ADULTS: 1) 18 YEARS OF AGE OR OLDER 2) PROFOUND, BILATERAL SENSORINEURAL DEAFNESS (>=90DB) 3) POSTLINGUALLY DEAFENED 4) LACK OF BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS.