|
Device | TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM |
Generic Name | Joint, temporomandibular, implant |
Regulation Number | 872.3940 |
Applicant | BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. JACKSONVILLE, FL 32218 |
PMA Number | P020016 |
Supplement Number | S002 |
Date Received | 09/11/2006 |
Decision Date | 10/13/2006 |
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 ARTHROTEK, INC.?S ONTARIO CALIFORNIA, FACILITY FOR THE PURCHASE OF RAW MATERIAL FOR THE MANDIBULAR BLANKS; THE CUTTING OF THIS RAW MATERIAL; AND THE ADDITION OF ANOTHER WIRE ELECTRICAL DISCHARGE MACHINE. |