PMA P960058S116
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S116
- Product code
- MCM
- Decision date
- 2015-11-24
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN VALENCIA, CALIFORNIA
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S116
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2015-11-24
- Decision code
- APPR
- Date received
- 2015-07-13
- 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 IN VALENCIA, CALIFORNIA