PMA P990052S014
- Device
- VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD)
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S014
- Product code
- MPV
- Decision date
- 2006-12-14
- Classification
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- ESTABLISH CENDRES & METAUX SA AS A SECOND SOURCE SUPPLIER FOR THE TITANIUM HOUSING OF THE FLOATING MASS TRANSDUCER (FMT ? A FUNCTIONAL COMPONENT OF VIBRATING OSSICULAR PROSTHESIS (VORP)).
Current openFDA PMA Record#
- Device
- VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD)
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S014
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2006-12-14
- Decision code
- OK30
- Date received
- 2006-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ESTABLISH CENDRES & METAUX SA AS A SECOND SOURCE SUPPLIER FOR THE TITANIUM HOUSING OF THE FLOATING MASS TRANSDUCER (FMT ? A FUNCTIONAL COMPONENT OF VIBRATING OSSICULAR PROSTHESIS (VORP)).