|
Device | LCS COMPLETE TOTAL KNEE SYSTEM |
Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P830055 |
Supplement Number | S115 |
Date Received | 11/01/2010 |
Decision Date | 03/11/2011 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1) AUTOMATING ALL MILLING/GRINDING PROCESSES THAT WERE PREVIOUSLY MANUAL; 2) USE OF AN OIL-BASED COOLANT DURING MILLING/ GRINDING; AND 3) INCLUDING A NEW PROCESS ¿ MANUAL IN-PROCESS CLEAN (IPC) TO REMOVE THE OIL-BASED COOLANT AFTER MILLING. |