CLARION CII BIONIC EAR SYSTEM (ADULT)
FDA premarket approval P940022/S026 · decided 2002-11-01
Approval details
- PMA number
- P940022
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Other
- Trade name
- CLARION CII BIONIC EAR SYSTEM (ADULT)
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics Corp.
- Date received
- 2002-10-25
- Decision date
- 2002-11-01
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- 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.
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