- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S038
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2004-08-24
- Decision code
- APPR
- Date received
- 2004-07-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.