Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceVIBRANT SOUNDBRIDGE SYSTEM
Generic NameImplant, hearing, active, middle ear, partially implanted
ApplicantMed-el Elektromedizinische Gerate GmbH
FUERSTENWEG 77A
A-6020
INNSBRUCK, TIROL 
PMA NumberP990052
Supplement NumberS022
Date Received11/16/2009
Decision Date07/27/2010
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE AMADÉ AUDIO PROCESSOR AND THE SYMFIT SYSTEM SOFTWARE VERSION 5.0.
-
-