HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S038 · decided 2004-08-24
Approval details
- PMA number
- P960058
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2004-07-28
- Decision date
- 2004-08-24
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- 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 FUR
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