AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S091 · decided 2012-04-27
Approval details
- PMA number
- P960058
- Supplement
- S091
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2011-09-30
- Decision date
- 2012-04-27
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL OF DESIGN CHANGES IMPLEMENTED IN THE APPROVED HIRES 90K COCHLEAR IMPLANT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME "HIRES+90KR ADVANTAGE", HEREAFTER REFERRED TO AS "ADVANTAGE." THIS MODIFIED COCHLEAR IMPLANT DESIGN WILL BEMARKETED UNDER A NEW MODEL NUMBER (CI-1500-XXX) AND THE BRAND NAME FOR THE HIRES 90K COCHLEAR IMPLANT, "AURIA HARMONY HIRCSOLUTION BIONIC EAR SYSTEM" WILL BE CHANGED TO "HIRESOLUTION BIONIC EAR SYSTEM." THE ADVANTAGE IMPLANT INCLUDES THE FO
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