HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S042 · decided 2005-09-21
Approval details
- PMA number
- P960058
- Supplement
- S042
- 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
- 2005-05-03
- Decision date
- 2005-09-21
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE FOR RECEIVING, RECEIVING INSPECTION, STAGING, PACKAGING FINISHED GOODS, AND SHIPPING LOCATED AT ADVANCED BIONICS, SYLMAR, CALIFORNIA.
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