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 proposed labeling changes following the conclusion of the postmarket surveillance study for the total temporomandibular joint replacement system.
| Device | TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM |
| Generic Name | Joint, Temporomandibular, Implant |
| Applicant | BIOMET MICROFIXATION, INC. |
| Date Received | 2016-12-14 |
| Decision Date | 2017-06-08 |
| PMA | P020016 |
| Supplement | S008 |
| Product Code | LZD |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOMET MICROFIXATION, INC. 1520 Tradeport Dr. jacksonville, FL 32218 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020016 | Original Filing | |
| S011 | 2019-11-18 | 30-day Notice |
| S010 | ||
| S009 | ||
| S008 | 2016-12-14 | Normal 180 Day Track No User Fee |
| S007 | 2014-11-10 | 30-day Notice |
| S006 | 2012-01-27 | 30-day Notice |
| S005 | 2010-05-18 | Normal 180 Day Track No User Fee |
| S004 | 2009-12-02 | Real-time Process |
| S003 | 2009-09-24 | Real-time Process |
| S002 | 2006-09-11 | Normal 180 Day Track No User Fee |
| S001 | 2006-04-28 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 00841036081898 | P020016 | 006 |
| 00841036060428 | P020016 | 006 |
| 00841036060398 | P020016 | 006 |
| 00841036060343 | P020016 | 006 |
| 00841036060329 | P020016 | 006 |
| 00841036036621 | P020016 | 006 |
| 00841036036607 | P020016 | 006 |
| 00841036036584 | P020016 | 006 |
| 00841036036560 | P020016 | 006 |
| 00841036036546 | P020016 | 006 |
| 00841036036522 | P020016 | 006 |
| 00841036036508 | P020016 | 006 |
| 00841036036454 | P020016 | 006 |
| 00841036036430 | P020016 | 006 |
| 00841036011895 | P020016 | 006 |
| 00841036011871 | P020016 | 006 |
| 00841036063580 | P020016 | 006 |
| 00841036064884 | P020016 | 006 |
| 00841036081881 | P020016 | 006 |
| 00841036081874 | P020016 | 006 |
| 00841036081867 | P020016 | 006 |
| 00841036081805 | P020016 | 006 |
| 00841036081799 | P020016 | 006 |
| 00841036081782 | P020016 | 006 |
| 00841036081744 | P020016 | 006 |
| 00841036081737 | P020016 | 006 |
| 00841036081720 | P020016 | 006 |
| 00841036081713 | P020016 | 006 |
| 00841036081560 | P020016 | 006 |
| 00841036081553 | P020016 | 006 |
| 00841036081386 | P020016 | 006 |
| 00841036081348 | P020016 | 006 |
| 00841036075118 | P020016 | 006 |
| 00841036011857 | P020016 | 006 |