HIRESOLUTION BIONIC EAR SYSTEM (HIRES 90K)
FDA premarket approval P960058/S030 · decided 2003-07-07
Approval details
- PMA number
- P960058
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM (HIRES 90K)
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2003-03-18
- Decision date
- 2003-07-07
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE REPACKAGED ICS (IMPLANTABLE COCHLEAR STIMULATOR), REFERRED TO AS HIRES 90K, AND ITS ASSOCIATED SURGICAL TOOLS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 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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