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 IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD) |
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 | S016 |
Date Received | 02/28/2007 |
Decision Date | 03/30/2007 |
Product Code |
MPV |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPDATE TO THE SHELF-LIFE INFORMATION OF THE SILICONE RUBBERS AND EPOXIES AND CHANGE TO THE COATING OF THE AUDIO PROCESSOR (AP) MAGNETS FROM ALUMINUM CHROMATE IV TO ALUMINUM PHOSPHATE. |
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