PMA P960058S078
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S078
- Product code
- MCM
- Decision date
- 2009-03-05
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- ADDITION OF VISUAL ACCEPTANCE CRITERIA TO THE RECEIVING INSPECTION INSTRUCTION.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S078
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2009-03-05
- Decision code
- OK30
- Date received
- 2009-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF VISUAL ACCEPTANCE CRITERIA TO THE RECEIVING INSPECTION INSTRUCTION.