HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S043 · decided 2005-12-23
Approval details
- PMA number
- P960058
- Supplement
- S043
- 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
- 2005-07-05
- Decision date
- 2005-12-23
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR PROCESS CONTROL IMPROVEMENTS TO THE HIRES90K COIL-CASE/ELECTRODE SUBASSEMBLY FINAL MOLDING PROCESS. THE PROPOSED CHANGES INCLUDE AN EXTERNAL THERMOCOUPLE TO PROVIDE CLOSED-LOOP CONTROL OF THE MOLD TEMPERATURE, THEREBY PROVIDING BETTER CONTROL OF THE CURING TEMPERATURE OF THE SILICONE, AND BY CONFIGURING THE MOLD TOOL WITH SPRING WASHER (BELLEVILLE WASHERS) TO ALLOW FOR SMOOTHER MOVEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AN
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