PMA P960058S053
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S053
- Product code
- MCM
- Decision date
- 2006-03-22
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE ELECTROSTATIC DISCHARGE (ESD) PRECAUTION IN THE HIRESOLUTION BIONIC EAR SYSTEM PACKAGE INSERT.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S053
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2006-03-22
- Decision code
- APPR
- Date received
- 2006-03-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE ELECTROSTATIC DISCHARGE (ESD) PRECAUTION IN THE HIRESOLUTION BIONIC EAR SYSTEM PACKAGE INSERT.