PMA P020016S003
- Device
- TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
- Applicant
- Biomet Microfixation, Inc.
- PMA number
- P020016
- Supplement
- S003
- Product code
- LZD
- Decision date
- 2009-10-21
- Generic name
- Joint, temporomandibular, implant
- Approval order statement
- APPROVAL FOR A STAND-ALONE SURGICAL TECHNIQUE MANUAL.
Current openFDA PMA Record#
- Device
- TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
- Applicant
- Biomet Microfixation, Inc.
- PMA number
- P020016
- Supplement
- S003
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2009-10-21
- Decision code
- APPR
- Date received
- 2009-09-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A STAND-ALONE SURGICAL TECHNIQUE MANUAL.