PMA P010023S008
- Device
- MAXUM SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S008
- Product code
- MPV
- Decision date
- 2011-03-02
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- CHANGE TO THE IPC SHELL FABRICATION PROCESS.
Current openFDA PMA Record#
- Device
- MAXUM SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S008
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2011-03-02
- Decision code
- OK30
- Date received
- 2010-12-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE IPC SHELL FABRICATION PROCESS.