PMA P960058S092
- Device
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S092
- Product code
- MCM
- Decision date
- 2011-10-26
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS TO IMPROVE AN INSERTION TOOL AND TO DOCUMENT A CHANGE IN THE TOOL SUPPLIERS.
Current openFDA PMA Record#
- Device
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S092
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2011-10-26
- Decision code
- OK30
- Date received
- 2011-10-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS TO IMPROVE AN INSERTION TOOL AND TO DOCUMENT A CHANGE IN THE TOOL SUPPLIERS.