PMA P960058S130
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S130
- Product code
- MCM
- Decision date
- 2018-08-13
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Modification of the Environmental Monitoring Plan for the manufacturing facilities in Valencia, California and Sylmar, California.
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S130
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2018-08-13
- Decision code
- OK30
- Date received
- 2018-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of the Environmental Monitoring Plan for the manufacturing facilities in Valencia, California and Sylmar, California.