PMA P990052S021
- Device
- VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S021
- Product code
- MPV
- Decision date
- 2008-10-24
- Classification
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- ADDITION OF TWO CLEAN-ROOMS AT THE AUSTRIA FACILITY.
Current openFDA PMA Record#
- Device
- VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S021
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2008-10-24
- Decision code
- OK30
- Date received
- 2008-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF TWO CLEAN-ROOMS AT THE AUSTRIA FACILITY.