PMA P960058S120
- Device
- HiRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S120
- Product code
- MCM
- Decision date
- 2017-05-17
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for the Sound Wave Professional Suite Software 3. 1, model number CI-6055-011.
Current openFDA PMA Record#
- Device
- HiRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S120
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2017-05-17
- Decision code
- APPR
- Date received
- 2016-11-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Sound Wave Professional Suite Software 3. 1, model number CI-6055-011.