PMA P990052S015
- Device
- VIBRANT SOUNDBRIDGE
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S015
- Product code
- MPV
- Decision date
- 2006-12-13
- Classification
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- APPROVAL FOR A CHANGE IN THE WORDING OF THE INDICATIONS FOR USE STATEMENT AND A NEW PRODUCT CODE DESCRIPTION THAT REMOVES THE REFERENCE TO HEARING AIDS. THE DEVICE IS INDICATED FOR USE IN ADULTS, 18 YEARS OF AGE OR OLDER, WHO HAVE A MODERATE TO SEVERE SENSORINEURAL HEARING LOSS. PRIOR TO RECEIVING THE DEVICE, IT IS RECOMMENDED THAT AN INDIVIDUAL HAVE EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
Current openFDA PMA Record#
- Device
- VIBRANT SOUNDBRIDGE
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S015
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2006-12-13
- Decision code
- APPR
- Date received
- 2006-11-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE IN THE WORDING OF THE INDICATIONS FOR USE STATEMENT AND A NEW PRODUCT CODE DESCRIPTION THAT REMOVES THE REFERENCE TO HEARING AIDS. THE DEVICE IS INDICATED FOR USE IN ADULTS, 18 YEARS OF AGE OR OLDER, WHO HAVE A MODERATE TO SEVERE SENSORINEURAL HEARING LOSS. PRIOR TO RECEIVING THE DEVICE, IT IS RECOMMENDED THAT AN INDIVIDUAL HAVE EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.