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 DIRECT DRIVE DEMONSTRATOR |
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 | S007 |
Date Received | 02/01/2002 |
Decision Date | 04/17/2002 |
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 THE ADDITION OF THE DIRECT DRIVE DEMONSTRATOR TO THE VIBRANT SOUNDBRIDGE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VIBRANT SOUNDBRIDGE DIRECT DRIVE DEMONSTRATOR. THE INDICATIONS FOR USE FOR THE DEVICE HAVE NOT CHANGED. |
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