PMA P960058S099
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S099
- Product code
- MCM
- Decision date
- 2013-08-19
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- CHANGE TO THE LI-ION RECHARGEABLE BATTERY PACK USED WITH THEPLATINUM SOUND PROCESSOR (PSP) AND THE S-SERIES SOUND PROCESSOR.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S099
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2013-08-19
- Decision code
- APPR
- Date received
- 2012-10-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- CHANGE TO THE LI-ION RECHARGEABLE BATTERY PACK USED WITH THEPLATINUM SOUND PROCESSOR (PSP) AND THE S-SERIES SOUND PROCESSOR.