PMA P990052S018
- Device
- VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S018
- Product code
- MPV
- Decision date
- 2007-06-13
- Classification
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- CHANGE TO THE STERILIZATION PROCESS PARAMETERS FOR THE VIBRANT SOUNDBRIDGE VIBRATING OSSICULAR PROSTHESIS IMPLANT.
Current openFDA PMA Record#
- Device
- VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S018
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2007-06-13
- Decision code
- OK30
- Date received
- 2007-05-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE STERILIZATION PROCESS PARAMETERS FOR THE VIBRANT SOUNDBRIDGE VIBRATING OSSICULAR PROSTHESIS IMPLANT.