Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VIBRANT SOUNDBRIDGE |
Generic Name | Implant, hearing, active, middle ear, partially implanted |
Applicant | Med-el Elektromedizinische Gerate GmbH FUERSTENWEG 77A A-6020 INNSBRUCK, TIROL |
PMA Number | P990052 |
Supplement Number | S015 |
Date Received | 11/24/2006 |
Decision Date | 12/13/2006 |
Product Code |
MPV |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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