PMA P010023
- Device
- MAXUM System
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S014
- Product code
- MPV
- Decision date
- 2020-10-28
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- Ethylene oxide (EO) sterilization process change for the implantable Magnet Canister Assembly.
Current openFDA PMA Record#
- Device
- MAXUM System
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S014
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2020-10-28
- Decision code
- OK30
- Date received
- 2020-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Ethylene oxide (EO) sterilization process change for the implantable Magnet Canister Assembly.