PMA P960058S124
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S124
- Product code
- MCM
- Decision date
- 2017-10-25
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Change to the in-house sterilization load configuration.
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S124
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2017-10-25
- Decision code
- OK30
- Date received
- 2017-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the in-house sterilization load configuration.