PMA P990052S007
- Device
- VIBRANT SOUNDBRIDGE DIRECT DRIVE DEMONSTRATOR
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S007
- Product code
- MPV
- Decision date
- 2002-04-17
- Classification
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE DIRECT DRIVE DEMONSTRATOR TO THE VIBRANT SOUNDBRIDGE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VIBRANT SOUNDBRIDGE DIRECT DRIVE DEMONSTRATOR. THE INDICATIONS FOR USE FOR THE DEVICE HAVE NOT CHANGED.
Current openFDA PMA Record#
- Device
- VIBRANT SOUNDBRIDGE DIRECT DRIVE DEMONSTRATOR
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S007
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2002-04-17
- Decision code
- APPR
- Date received
- 2002-02-01
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE DIRECT DRIVE DEMONSTRATOR TO THE VIBRANT SOUNDBRIDGE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VIBRANT SOUNDBRIDGE DIRECT DRIVE DEMONSTRATOR. THE INDICATIONS FOR USE FOR THE DEVICE HAVE NOT CHANGED.