PMA P960058S075
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S075
- Product code
- MCM
- Decision date
- 2009-06-12
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR IMPROVEMENTS TO THE MANUFACTURING PROCESS FOR THE MAGNET ASSEMBLY USED IN THE HIRES90K IMPLANTABLE COCHLEAR STIMULATOR.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S075
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2009-06-12
- Decision code
- APPR
- Date received
- 2008-11-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR IMPROVEMENTS TO THE MANUFACTURING PROCESS FOR THE MAGNET ASSEMBLY USED IN THE HIRES90K IMPLANTABLE COCHLEAR STIMULATOR.