PMA P940022S025

Device: CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S025
Product code: MCM
Decision date: 2002-09-23
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR CHANGING THE PRODUCT NAME OF THE HIRES SOFTWARE, MODEL NUMBER CI-6055. THE SOFTWARE WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE, MODEL NUMBER CI-6055, AND IS INDICATED FOR USE IN 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: CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S025
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2002-09-23
Decision code: APPR
Date received: 2002-09-19
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGING THE PRODUCT NAME OF THE HIRES SOFTWARE, MODEL NUMBER CI-6055. THE SOFTWARE WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE, MODEL NUMBER CI-6055, AND IS INDICATED FOR USE IN 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).