PMA P960058S136
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S136
- Product code
- MCM
- Decision date
- 2019-03-08
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Modification of the software controlling the sterilization chamber at Sterigenics, Salt Lake City, Utah.
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S136
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2019-03-08
- Decision code
- OK30
- Date received
- 2019-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of the software controlling the sterilization chamber at Sterigenics, Salt Lake City, Utah.