PMA P960058S150
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S150
- Product code
- MCM
- Decision date
- 2020-07-22
- Generic name
- Implant, cochlear
- Approval order statement
- Expansion to an existing implant capacitor supplier to provide additional capacitors for Ultra Family of cochlear implants to enhance the supply chain.
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S150
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2020-07-22
- Decision code
- OK30
- Date received
- 2020-06-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion to an existing implant capacitor supplier to provide additional capacitors for Ultra Family of cochlear implants to enhance the supply chain.