HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S113 · decided 2014-12-12
Approval details
- PMA number
- P960058
- Supplement
- S113
- Supplement type
- 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
- 2014-11-13
- Decision date
- 2014-12-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- RELOCATE THE ICS HYBRID SERIALIZATION PROCESS FROM THE HYBRID MANUFACTURER TO IN-HOUSE HYBRID SERIALIZATION PROCESS AT ADVANCED BIONICS.
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