PMA P960058S101
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S101
- Product code
- MCM
- Decision date
- 2013-09-17
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- IMPROVEMENT TO THE HIRESOLUTION BIONIC EAR SYSTEM¿S HYBRID INSPECTION PROCESS.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S101
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2013-09-17
- Decision code
- APPR
- Date received
- 2012-11-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPROVEMENT TO THE HIRESOLUTION BIONIC EAR SYSTEM¿S HYBRID INSPECTION PROCESS.