HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S075 · decided 2009-06-12
Approval details
- PMA number
- P960058
- Supplement
- S075
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2008-11-18
- Decision date
- 2009-06-12
- Days to decision
- 206 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR IMPROVEMENTS TO THE MANUFACTURING PROCESS FOR THE MAGNET ASSEMBLY USED IN THE HIRES90K IMPLANTABLE COCHLEAR STIMULATOR.
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