- Device
- VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S020
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2009-01-09
- Decision code
- APPR
- Date received
- 2008-08-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROSE GMBH, TRIER, GERMANY TO PERFORM STERILIZATION ACTIVITIES.