HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S054 · decided 2006-07-28
Approval details
- PMA number
- P960058
- Supplement
- S054
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2006-07-17
- Decision date
- 2006-07-28
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A COCHLEAR IMPLANT SYSTEM NAME CHANGE FROM "HIRESOLUTION BIONIC EAR SYSTEM" TO "HARMONY HIRESOLUTION BIONIC EAR SYSTEM". THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HARMONY HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS AND THE PEDIATRIC POPULATION AGED 12 MONTHS THROUGH 17 YEARS, 11 MONTHS OF AGE.
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