VIBRANT SOUNDBRIDGE EAR IMPLANT SYSTEM

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Premarket Approval P990052 S019

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 for a minor software change to the currently approved symfit module and is indicated for adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids.

DeviceVIBRANT SOUNDBRIDGE EAR IMPLANT SYSTEM
Classification NameImplant, Hearing, Active, Middle Ear, Partially Implanted
Generic NameImplant, Hearing, Active, Middle Ear, Partially Implanted
ApplicantMed-el Elektromedizinische Gerate GmbH
Date Received2008-01-22
Decision Date2008-03-25
PMAP990052
SupplementS019
Product CodeMPV
Advisory CommitteeEar Nose & Throat
Supplement TypeReal-time Process
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
09008738501531 P990052 000
09008738508981 P990052 000
09008738501562 P990052 000
09008738501135 P990052 003
09008738501128 P990052 003
09008738501142 P990052 003
09008738501111 P990052 008
09008738501104 P990052 008
09008738501463 P990052 011
09008738501531 P990052 011
09008738510687 P990052 011
09008738501562 P990052 011
09008738504563 P990052 022
09008738504587 P990052 022
09008738504556 P990052 022
09008738504723 P990052 022
09008738510687 P990052 022
09008738504570 P990052 022
09008738504594 P990052 022
09008738504600 P990052 022
09008738504617 P990052 022
09008738504761 P990052 022
09008738504754 P990052 022
09008738504785 P990052 022
09008738504747 P990052 022
09008738504730 P990052 022
09008738504716 P990052 022
09008738504709 P990052 022
09008738504693 P990052 022
09008738504686 P990052 022
09008738504679 P990052 022
09008738504662 P990052 022
09008738504655 P990052 022
09008738504648 P990052 022
09008738504631 P990052 022
09008738504624 P990052 022
09008738504778 P990052 022
09008738500558 P990052 023
09008737526139 P990052 026
09008737525378 P990052 026
09008737525361 P990052 026
09008737525354 P990052 026
09008737525347 P990052 026
09008737525316 P990052 026
09008737525309 P990052 026
09008737525293 P990052 026
09008737526146 P990052 026
09008737526153 P990052 026
09008737526160 P990052 026
09008737526481 P990052 026
09008737526474 P990052 026
09008737526467 P990052 026
09008737526450 P990052 026
09008737526429 P990052 026
09008737526412 P990052 026
09008737526405 P990052 026
09008737526399 P990052 026
09008737525286 P990052 026

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.