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.
 
DeviceHIRESOLUTION BIONIC EAR SYSTEM
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Supplement NumberS038
Date Received07/28/2004
Decision Date08/24/2004
Product Code MCM 
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 FOR AN INTERIM DESIGN CHANGE FOR THE AURIA POWERPAK ACCESSORY TO THE HIRESOLUTION BIONIC EAR SYSTEM. SPECIFICALLY, YOU PROPOSE THE ADDITION OF AN INSULATING WASHER TO THE AURIA POWERPAK ASSEMBLY WHILE YOU DEVELOP A FINAL DESIGN SOLUTION FOR THE RECENTLY DISCOVERED SAFETY ISSUE ASSOCIATED WITH THIS DEVICE. WE NOTE THAT YOU AGREE TO DESIGN, TEST, MANUFACTURE, AND DISTRIBUTE THE REVISED AURIA POWERPAK MODEL WITH THE FINAL DESIGN SOLUTION WITHIN SIX MONTHS OF THE DATE OF THIS LETTER. WE FURTHER NOTE THAT YOU AGREE TO SUBMIT A SUPPLEMENT TO FDA FOR THE PROPOSED FINAL DESIGN ONCE THE DESIGN AND TEST ACTIVITIES HAVE BEEN COMPLETE AND WILL NOT DISTRIBUTE THE REVISED AURIA POWERPAK WITHOUT FDA APPROVAL.
-
-