PMA P960058S098
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S098
- Product code
- MCM
- Decision date
- 2013-05-20
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR AN ALTERNATE ELECTRODE CONFIGURATION FOR THE HIRES 90K ADVANTAGE COCHLEAR IMPLANT DEVICE, THE "HI FOCUS MID-SCALA ELECTRODE.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S098
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2013-05-20
- Decision code
- APPR
- Date received
- 2012-09-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ALTERNATE ELECTRODE CONFIGURATION FOR THE HIRES 90K ADVANTAGE COCHLEAR IMPLANT DEVICE, THE "HI FOCUS MID-SCALA ELECTRODE.