PMA P020016
- Device
- Total Temporomandibular Joint Replacement System
- Applicant
- Biomet Microfixation, Inc.
- PMA number
- P020016
- Supplement
- S011
- Product code
- LZD
- Decision date
- 2026-07-27
- Generic name
- Joint, Temporomandibular, Implant
- Approval order statement
- APPROVAL FOR PROPOSED LABELING CHANGES FOLLOWING THE CONCLUSION OF THE POSTMARKET SURVEILLANCE STUDY FOR THE TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.
Current openFDA PMA Record#
- Device
- Total Temporomandibular Joint Replacement System
- Applicant
- Biomet Microfixation, Inc.
- PMA number
- P020016
- Supplement
- S010
- Decision date
- 2026-07-27
- Decision code
- APPR
- Date received
- 2018-10-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR PROPOSED LABELING CHANGES FOLLOWING THE CONCLUSION OF THE POSTMARKET SURVEILLANCE STUDY FOR THE TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.