PMA P010023S007
- Device
- MAXUM SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S007
- Product code
- MPV
- Decision date
- 2012-05-10
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE WIREFORM COIL THAT IS USED TO ATTACH THE IMPLANT ASSEMBLY TO THE OSSICULAR CHAIN.
Current openFDA PMA Record#
- Device
- MAXUM SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S007
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2012-05-10
- Decision code
- APPR
- Date received
- 2010-10-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE WIREFORM COIL THAT IS USED TO ATTACH THE IMPLANT ASSEMBLY TO THE OSSICULAR CHAIN.