PMA P960058S055
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S055
- Product code
- MCM
- Decision date
- 2007-02-26
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE FIXTURE (T7181) USED IN THE HELIUM LEAK TESTING OF THE HIRES90K IMPLANT.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S055
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2007-02-26
- Decision code
- APPR
- Date received
- 2006-10-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE FIXTURE (T7181) USED IN THE HELIUM LEAK TESTING OF THE HIRES90K IMPLANT.