PMA P960058S095
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S095
- Product code
- MCM
- Decision date
- 2012-06-15
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ADVANCED BIONICS, LLC AND A FINISHED GOODS WAREHOUSE LOCATED IN VALENCIA, CALIFORNIA.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S095
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2012-06-15
- Decision code
- APPR
- Date received
- 2011-12-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ADVANCED BIONICS, LLC AND A FINISHED GOODS WAREHOUSE LOCATED IN VALENCIA, CALIFORNIA.