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 prosthesis(tm). The device is indicated for use in treatment of severe temporomandibular joint disease due to: 1) inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment, 2) recurrent fibrosis and/or bony ankylosis not responsive to other modalities of treatment, 3) failed tissue graft, 4) failed alloplastic joint reconstruction, 5) internal derangement confirmed to be pathological in origin by both clinical observation and radiographic findings, where the patient has moderate to severe pain and/or disabling dysfunction and has not responded to less invasive conventional therapy.
| Device | TMJ FOSSA-EMINENCE PROSTHESIS(TM) |
| Generic Name | Glenoid Fossa Prosthesis |
| Applicant | NEXUS CMF, LLC |
| Date Received | 2000-06-20 |
| Decision Date | 2001-02-27 |
| Notice Date | 2001-05-14 |
| PMA | P000035 |
| Supplement | S |
| Product Code | MPI |
| Docket Number | 01M-0210 |
| 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 |
|---|---|---|
| P000035 | 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 |