|
Device | VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT 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 | S012 |
Date Received | 12/01/2005 |
Decision Date | 10/13/2006 |
Product Code |
MPV |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT MED-EL ELEKTROMEDIZINISCHE GERATE (CONTRACT MANUFACTURER FOR VIBRANT MED-EL) GMBH OF INNSBRUCK, AUSTRIA, FOR THE LASER WELDING OF THE PRE WELDED DEMODULATOR UNIT AND THE BOBBIN. |