PMA P010023S009
- Device
- MAXUM SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S009
- Product code
- MPV
- Decision date
- 2011-07-15
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- APPROVAL OF A MANUFACTURING PROCESS AND SUPPLIER CHANGE TO THE MAGNET CANISTER ASSEMBLY.
Current openFDA PMA Record#
- Device
- MAXUM SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S009
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2011-07-15
- Decision code
- APPR
- Date received
- 2011-04-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL OF A MANUFACTURING PROCESS AND SUPPLIER CHANGE TO THE MAGNET CANISTER ASSEMBLY.