PMA P960058S154
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S154
- Product code
- MCM
- Decision date
- 2022-01-14
- Generic name
- Implant, cochlear
- Approval order statement
- Introduction of new roll-band sealers used by the supplier for preparing seal pouches for sterilization.
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S154
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2022-01-14
- Decision code
- OK30
- Date received
- 2021-12-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of new roll-band sealers used by the supplier for preparing seal pouches for sterilization.