PMA P960058S074
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S074
- Product code
- MCM
- Decision date
- 2009-03-11
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL TO CHANGE TO THE PLATINUM SOLID RING.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S074
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2009-03-11
- Decision code
- APPR
- Date received
- 2008-11-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO CHANGE TO THE PLATINUM SOLID RING.