PMA P960058S097
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S097
- Product code
- MCM
- Decision date
- 2012-08-24
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- CHANGE IN THE BIOLOGICAL INDICATOR USED IN THE FIRM¿S ETHYLENE OXIDE STERILIZATION PROCESS.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S097
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2012-08-24
- Decision code
- OK30
- Date received
- 2012-07-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE BIOLOGICAL INDICATOR USED IN THE FIRM¿S ETHYLENE OXIDE STERILIZATION PROCESS.