PMA P960058S008
- Device
- MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S008
- Decision date
- 1999-01-19
- Approval order statement
- Approval for expansion of the indication for use of the Advanced Bionics CLARION Multi-Strategy Cochlear Implant to include children 18 months and older.
Current openFDA PMA Record#
- Device
- MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S008
- Decision date
- 1999-01-19
- Decision code
- APPR
- Date received
- 1998-10-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for expansion of the indication for use of the Advanced Bionics CLARION Multi-Strategy Cochlear Implant to include children 18 months and older.