PMA P020016S011
- Device
- Total Temporomandibular Joint Replacement System
- Applicant
- Biomet Microfixation, Inc.
- PMA number
- P020016
- Supplement
- S011
- Product code
- LZD
- Decision date
- 2019-12-17
- Generic name
- Joint, temporomandibular, implant
- Approval order statement
- Implementation of updates to the Prints, Inspection Overlays, and Machine program headers of the TMJ Fossa Components.
Current openFDA PMA Record#
- Device
- Total Temporomandibular Joint Replacement System
- Applicant
- Biomet Microfixation, Inc.
- PMA number
- P020016
- Supplement
- S011
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2019-12-17
- Decision code
- OK30
- Date received
- 2019-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of updates to the Prints, Inspection Overlays, and Machine program headers of the TMJ Fossa Components.