Note: 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. |
|
Device | TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES |
Generic Name | Joint, temporomandibular, implant |
Regulation Number | 872.3940 |
Applicant | NEXUS CMF, LLC 17301 WEST COLFAX AVENUE SUITE 170 GOLDEN, CO 80401 |
PMA Number | P000023 |
Date Received | 06/20/2000 |
Decision Date | 01/05/2001 |
Product Code |
LZD |
Docket Number | 01M-0255 |
Notice Date | 06/11/2001 |
Advisory Committee |
Dental |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 |
|
|