Implant, Cochlear
Basic Information
- Device Name
- Implant, Cochlear
- Trade Name
- HIRESOLUTION BIONIC EAR SYSTEM
- PMA Number
- P960058
- Supplement Number
- S038
- Device Class
- FDA Class 3
- Product Code
- MCM
- Generic Name
- Implant, cochlear
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 24, 2004
- Date Received
- July 28, 2004
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCM | Implant, Cochlear | FDA class 3 | Unknown |