Note: 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. |
|
Device | TMJ FOSSA EMINENCE/CONDYLAR PROSTHESIS SYSTEM |
Generic Name | Glenoid fossa prosthesis |
Regulation Number | 872.3950 |
Applicant | NEXUS CMF, LLC 17301 WEST COLFAX AVENUE SUITE 170 GOLDEN, CO 80401 |
PMA Number | P000035 |
Supplement Number | S003 |
Date Received | 06/20/2002 |
Decision Date | 01/22/2004 |
Product Code |
MPI |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW MANUFACTURING SITE FOR THE CRYSTALCLEAR ANATOMICAL MODEL. THE SITE IS LOCATED AT TMJ IMPLANTS, INC., GOLDEN, COLORADO. |
Post-Approval Study | Show Report Schedule and Study Progress |
|
|