|
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 | S001 |
Date Received | 04/28/2006 |
Decision Date | 05/26/2006 |
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 WALTER LORENZ SURGICAL, INC.S JACKSONVILLE, FLORIDA FACILITY FOR THE WIRE ELECTRICAL DISCHARGE MACHINING MANUFACTURING PROCESS. |