HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S058 · decided 2007-07-02
Approval details
- PMA number
- P960058
- Supplement
- S058
- 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
- 2007-05-07
- Decision date
- 2007-07-02
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THREE ?VACUUM BAKE AIR FLOW ENHANCEMENTS? TO THE HIRES90K COCHLEAR IMPLANT, AS FOLLOWS: 1) THE BOTTOM COVER SHIELD INSIDE THE HIRES90K CASE WAS MODIFIED FROM HAVING A ?V?-SHAPED CHANNEL TO HAVING A LARGER ?U?-SHAPED CHANNEL. 2) HOLES WERE ADDED TO THE INSULATING KAPTON DISC. 3) SLOTS WERE IMPLEMENTED INSIDE THE FEEDTHROUGH CASE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR INDIVIDUALS AGED 12-MONTHS AND OLDER WITH
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