PMA P960058S085
- Device
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S085
- Product code
- MCM
- Decision date
- 2010-08-24
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR A NEW VERSION OF FITTING SOFTWARE, CALLED SOUNDWAVE 2.0.
Current openFDA PMA Record#
- Device
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S085
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2010-08-24
- Decision code
- APPR
- Date received
- 2010-05-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW VERSION OF FITTING SOFTWARE, CALLED SOUNDWAVE 2.0.