PMA P960058S117
- Device
- HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S117
- Product code
- MCM
- Decision date
- 2016-07-15
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval Order should be issued for this PMA supplement.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S117
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2016-07-15
- Decision code
- APPR
- Date received
- 2015-08-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval Order should be issued for this PMA supplement.