PMA P990052S008
- Device
- VIBRANT SOUNDBRIDGE SYSTEM
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S008
- Product code
- MPV
- Decision date
- 2002-07-02
- Classification
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- APPROVAL FOR CHANGES TO THE MANUFACTURING SPECIFICATION CRITERIA FOR THE FLOATING MASS TRANSDUCER.
Current openFDA PMA Record#
- Device
- VIBRANT SOUNDBRIDGE SYSTEM
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S008
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2002-07-02
- Decision code
- APPR
- Date received
- 2002-05-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE MANUFACTURING SPECIFICATION CRITERIA FOR THE FLOATING MASS TRANSDUCER.