PMA P960058S080
- Device
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S080
- Product code
- MCM
- Decision date
- 2010-06-11
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR THE ADDITION OF A MOISTURE GETTER MATERIAL IN THE HIRES90KL COCHLEAR IMPLANT AS A PREVENTIVE MEASURE IN THE UNLIKELY EVENT OF A HERMETIC FAILURE.
Current openFDA PMA Record#
- Device
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S080
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2010-06-11
- Decision code
- APPR
- Date received
- 2009-03-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF A MOISTURE GETTER MATERIAL IN THE HIRES90KL COCHLEAR IMPLANT AS A PREVENTIVE MEASURE IN THE UNLIKELY EVENT OF A HERMETIC FAILURE.