This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the tmj fossa-eminence/condylar prosthesis system. The device is indicated for reconstruction of the temporomandibular joint. Patients should be considered if they have one or more of the following conditions: 1) inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment 2) recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment 3) failed tissue graft 4) failed alloplastic joint reconstruction 5) loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion.
| Device | TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES |
| Generic Name | Joint, Temporomandibular, Implant |
| Applicant | NEXUS CMF, LLC |
| Date Received | 2000-06-20 |
| Decision Date | 2001-01-05 |
| Notice Date | 2001-06-11 |
| PMA | P000023 |
| Supplement | S |
| Product Code | LZD |
| Docket Number | 01M-0255 |
| Advisory Committee | Dental |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEXUS CMF, LLC 17301 West Colfax Avenue suite 170 golden, CO 80401 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000023 | Original Filing | |
| S011 | 2015-01-16 | 30-day Notice |
| S010 | 2014-05-02 | 30-day Notice |
| S009 | 2014-03-04 | Real-time Process |
| S008 | 2012-05-03 | 135 Review Track For 30-day Notice |
| S007 | 2011-08-29 | Normal 180 Day Track No User Fee |
| S006 | 2011-05-11 | Normal 180 Day Track No User Fee |
| S005 | ||
| S004 | 2002-12-26 | Normal 180 Day Track |
| S003 | 2002-06-20 | Normal 180 Day Track |
| S002 | 2002-06-20 | Normal 180 Day Track |
| S001 | 2002-06-18 | Normal 180 Day Track |