VIBRANT SOUNDBRIDGE SYSTEM

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Premarket Approval P990052 S022

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.

Pre-market Approval Supplement Details

Approval of the amadÉ audio processor and the symfit system software version 5. 0.

DeviceVIBRANT SOUNDBRIDGE SYSTEM
Classification NameImplant, Hearing, Active, Middle Ear, Partially Implanted
Generic NameImplant, Hearing, Active, Middle Ear, Partially Implanted
ApplicantMed-el Elektromedizinische Gerate GmbH
Date Received2009-11-16
Decision Date2010-07-27
PMAP990052
SupplementS022
Product CodeMPV
Advisory CommitteeEar Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Med-el Elektromedizinische Gerate GmbH fuerstenweg 77a a-6020 innsbruck, Tirol 

Supplemental Filings

Supplement NumberDateSupplement Type
P990052Original Filing
S026 2022-07-14 Real-time Process
S025
S024 2013-12-20 30-day Notice
S023 2013-09-27 Real-time Process
S022 2009-11-16 Normal 180 Day Track
S021 2008-09-24 30-day Notice
S020 2008-08-22 Normal 180 Day Track No User Fee
S019 2008-01-22 Real-time Process
S018 2007-05-14 30-day Notice
S017
S016 2007-02-28 30-day Notice
S015 2006-11-24 Real-time Process
S014 2006-11-13 30-day Notice
S013 2006-07-12 135 Review Track For 30-day Notice
S012 2005-12-01 Normal 180 Day Track No User Fee
S011 2004-04-08 Normal 180 Day Track No User Fee
S010
S009
S008 2002-05-01 Normal 180 Day Track
S007 2002-02-01 Real-time Process
S006 2001-09-24 Normal 180 Day Track
S005
S004 2001-06-20 Real-time Process
S003 2001-03-09 Normal 180 Day Track
S002 2000-11-03 Normal 180 Day Track
S001 2000-09-12 Real-time Process

NIH GUDID Devices

Device IDPMASupp
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