This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for labeling changes to update the owner and company name, manufacturing suite, standardization of the product names, and adverse events section related to completion of the post-approval study.
| Device | TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM |
| Generic Name | Joint, Temporomandibular, Implant |
| Applicant | NEXUS CMF, LLC |
| Date Received | 2011-05-11 |
| Decision Date | 2012-01-31 |
| PMA | P000023 |
| Supplement | S006 |
| Product Code | LZD |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEXUS CMF, LLC 17301 West Colfax Avenue suite 170 golden, CO 80401 |
| 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 |