HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S095 · decided 2012-06-15
Approval details
- PMA number
- P960058
- Supplement
- S095
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2011-12-30
- Decision date
- 2012-06-15
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ADVANCED BIONICS, LLC AND A FINISHED GOODS WAREHOUSE LOCATED IN VALENCIA, CALIFORNIA.
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