HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S053 · decided 2006-03-22
Approval details
- PMA number
- P960058
- Supplement
- S053
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2006-03-08
- Decision date
- 2006-03-22
- Days to decision
- 14 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 ELECTROSTATIC DISCHARGE (ESD) PRECAUTION IN THE HIRESOLUTION BIONIC EAR SYSTEM PACKAGE INSERT.
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