HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S055 · decided 2007-02-26
Approval details
- PMA number
- P960058
- Supplement
- S055
- 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
- 2006-10-17
- Decision date
- 2007-02-26
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A MODIFICATION TO THE FIXTURE (T7181) USED IN THE HELIUM LEAK TESTING OF THE HIRES90K IMPLANT.
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