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 the "surgeon's manual. "
| Device | FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM |
| Generic Name | Joint, Temporomandibular, Implant |
| Applicant | NEXUS CMF, LLC |
| Date Received | 2002-06-18 |
| Decision Date | 2002-09-12 |
| PMA | P000023 |
| Supplement | S001 |
| Product Code | LZD |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track |
| 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 |