PMA P990052S023
- Device
- VIBRANT SOUNDBRIDGE SYSTEM
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S023
- Product code
- MPV
- Decision date
- 2013-12-19
- Classification
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- APPROVAL FOR A VORP SIZER KIT. THIS INCLUDES A MINOR MODIFICATION (MATERIAL CHANGE) TO THE VORP TEMPLATE AND THE ADDITION OF THE FLOATING MASS TRANSDUCER (FMT) SIZER FOR OPTIONAL USE DURING VIBRANT SOUNDBRIDGE IMPLANTATION SURGERY.
Current openFDA PMA Record#
- Device
- VIBRANT SOUNDBRIDGE SYSTEM
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S023
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2013-12-19
- Decision code
- APPR
- Date received
- 2013-09-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A VORP SIZER KIT. THIS INCLUDES A MINOR MODIFICATION (MATERIAL CHANGE) TO THE VORP TEMPLATE AND THE ADDITION OF THE FLOATING MASS TRANSDUCER (FMT) SIZER FOR OPTIONAL USE DURING VIBRANT SOUNDBRIDGE IMPLANTATION SURGERY.