PMA P960058S007
- Device
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S007
- Decision date
- 1999-02-19
- Approval order statement
- Approval for a manufacturing process change in which the implantable cochlear stimulator (ICS) case will be darkened using titanium.
Current openFDA PMA Record#
- Device
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S007
- Decision date
- 1999-02-19
- Decision code
- APPR
- Date received
- 1998-09-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing process change in which the implantable cochlear stimulator (ICS) case will be darkened using titanium.