HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S036 · decided 2004-08-04
Approval details
- PMA number
- P960058
- Supplement
- S036
- Supplement type
- Normal 180 Day 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
- 2004-04-22
- Decision date
- 2004-08-04
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR LABELING CHANGES TO INDICATE THAT THE HIRESOLUTION BIONIC EAR SYSTEM IS SAFE FOR MRI AT LEVELS OF 0.3 TESLA/12 MHZ AND 1.5 TESLA/64 MHZ.
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