PMA P960058S036
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S036
- Product code
- MCM
- Decision date
- 2004-08-04
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order 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.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S036
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2004-08-04
- Decision code
- APPR
- Date received
- 2004-04-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.