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 SYSTEM |
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 | S006 |
Date Received | 09/24/2001 |
Decision Date | 10/26/2001 |
Product Code |
MPV |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN CHANGES TO THE AUDIO PROCESSOR MODEL 404. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VIBRANT(R) SOUNDBRIDGE(TM) AUDIO PROCESSOR MODEL 404SR. THE INDICATIONS FOR USE FOR THE DEVICE HAVE NOT CHANGED. |
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