PMA P960058S050
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S050
- Product code
- MCM
- Decision date
- 2006-01-17
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL OF THE REDUCED RESIDUAL GAS ANALYSIS (RGA-A DESTRUCTIVE TEST) LOT SAMPLING FOR THE HIRES90K IMPLANT.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S050
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2006-01-17
- Decision code
- OK30
- Date received
- 2005-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL OF THE REDUCED RESIDUAL GAS ANALYSIS (RGA-A DESTRUCTIVE TEST) LOT SAMPLING FOR THE HIRES90K IMPLANT.