PMA P960058S026

Device: CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S026
Product code: MCM
Decision date: 2002-11-01
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES TO THE POSTMARKET STUDY PROTOCOL: 1) USE OF ONLY THE PB-K TEST TO DETERMINE CANDIDACY IN CHILDREN 4 YEARS THROUGH 17 YEARS OF AGE AT TIME OF IMPLANT. 2) SUBSTITUTION OF THE PB-K TEST FOR THE ESP TEST AS AN OUTCOME MEASURE. 3) DIVISION OF THE YOUNGEST AGE GROUP INTO TWO GROUPS. 4) ADDITIONAL INCLUSION/EXCLUSION CRITERIA FOR ADULTS AND CHILDREN.

Current openFDA PMA Record#

Device: CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S026
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2002-11-01
Decision code: APPR
Date received: 2002-10-25
Supplement type: Real-Time Process
Supplement reason: Postapproval Study Protocol
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES TO THE POSTMARKET STUDY PROTOCOL: 1) USE OF ONLY THE PB-K TEST TO DETERMINE CANDIDACY IN CHILDREN 4 YEARS THROUGH 17 YEARS OF AGE AT TIME OF IMPLANT. 2) SUBSTITUTION OF THE PB-K TEST FOR THE ESP TEST AS AN OUTCOME MEASURE. 3) DIVISION OF THE YOUNGEST AGE GROUP INTO TWO GROUPS. 4) ADDITIONAL INCLUSION/EXCLUSION CRITERIA FOR ADULTS AND CHILDREN.