PMA P960058S066
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S066
- Product code
- MCM
- Decision date
- 2008-10-15
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR AN IMPROVED AUTOMATED TEST SYSTEM FOR THE HIRES90K.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S066
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2008-10-15
- Decision code
- APPR
- Date received
- 2008-06-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN IMPROVED AUTOMATED TEST SYSTEM FOR THE HIRES90K.