PMA P960058S153
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S153
- Product code
- MCM
- Decision date
- 2021-04-29
- Generic name
- Implant, cochlear
- Approval order statement
- Implantation of Assemble-to-Order process functionality within the ERP (Enterprise Resource Planning) system.
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S153
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2021-04-29
- Decision code
- OK30
- Date received
- 2021-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implantation of Assemble-to-Order process functionality within the ERP (Enterprise Resource Planning) system.