|
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. |