|
Device | TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM |
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 |
Supplement Number | S007 |
Date Received | 08/29/2011 |
Decision Date | 06/27/2012 |
Product Code |
LZD |
Advisory Committee |
Dental |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT TMJ MEDICAL IN GOLDEN, COLORADO. |