PMA P990052S016
- Device
- VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD)
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S016
- Product code
- MPV
- Decision date
- 2007-03-30
- Classification
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- UPDATE TO THE SHELF-LIFE INFORMATION OF THE SILICONE RUBBERS AND EPOXIES AND CHANGE TO THE COATING OF THE AUDIO PROCESSOR (AP) MAGNETS FROM ALUMINUM CHROMATE IV TO ALUMINUM PHOSPHATE.
Current openFDA PMA Record#
- Device
- VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD)
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S016
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2007-03-30
- Decision code
- OK30
- Date received
- 2007-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATE TO THE SHELF-LIFE INFORMATION OF THE SILICONE RUBBERS AND EPOXIES AND CHANGE TO THE COATING OF THE AUDIO PROCESSOR (AP) MAGNETS FROM ALUMINUM CHROMATE IV TO ALUMINUM PHOSPHATE.