PMA P960058S115
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S115
- Product code
- MCM
- Decision date
- 2015-05-19
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR A NEW CONFIGURATION TO THE HIFOCUS MID-SCALA (HFMS) ELECTRODEINSTRUMENT KIT, NAMELY A STANDALONE HFMS ELECTRODE INSERTION TOOL (MODEL NUMBER CI-4207).
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S115
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2015-05-19
- Decision code
- APPR
- Date received
- 2015-02-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW CONFIGURATION TO THE HIFOCUS MID-SCALA (HFMS) ELECTRODEINSTRUMENT KIT, NAMELY A STANDALONE HFMS ELECTRODE INSERTION TOOL (MODEL NUMBER CI-4207).