PMA P990052S024
- Device
- VIBRANT SOUNDBRIDGE
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S024
- Product code
- MPV
- Decision date
- 2014-02-13
- Classification
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- USE OF AN ALTERNATE SUPPLIER OF BOND COATING MATERIAL, USE OF AN ALTERNATE WIRE SUPPLIER, AND CHANGES TO THE SLEEVE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- VIBRANT SOUNDBRIDGE
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S024
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2014-02-13
- Decision code
- OK30
- Date received
- 2013-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN ALTERNATE SUPPLIER OF BOND COATING MATERIAL, USE OF AN ALTERNATE WIRE SUPPLIER, AND CHANGES TO THE SLEEVE MANUFACTURING PROCESS.