HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S079 · decided 2009-03-18
Approval details
- PMA number
- P960058
- Supplement
- S079
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2009-02-23
- Decision date
- 2009-03-18
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE HIRES 90K MOCK-UP AS STERILE INSTEAD OF NON-STERILE, AND TO ESTABLISH THE SHELF LIFE AT THREE YEARS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HARMONY HIRESOLUTION BIONIC EAR SYSTEM HIRES 90K MOCK-UP (MOCK-UP) AND IS INDICATED FOR INDIVIDUALS AGED TWELVE MONTHS AND OLDER WITH SEVERE-TO PROFOUND SENSORINEURAL HEARING LOSS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.
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