PMA P960058S113
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S113
- Product code
- MCM
- Decision date
- 2014-12-12
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- RELOCATE THE ICS HYBRID SERIALIZATION PROCESS FROM THE HYBRID MANUFACTURER TO IN-HOUSE HYBRID SERIALIZATION PROCESS AT ADVANCED BIONICS.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S113
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2014-12-12
- Decision code
- OK30
- Date received
- 2014-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- RELOCATE THE ICS HYBRID SERIALIZATION PROCESS FROM THE HYBRID MANUFACTURER TO IN-HOUSE HYBRID SERIALIZATION PROCESS AT ADVANCED BIONICS.