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 | LCS 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 | S094 |
Date Received | 12/19/2005 |
Decision Date | 01/20/2006 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE TO THE LABELING IN THE PACKAGE INSERT OF THE DEVICE. THIS MODIFICATION CLARIFIES THE TYPE OF LCS PATELLAR COMPONENT (LCS PFJ MODIFIED ROTATING PLATFORM PATELLA) TO BE USED WITH THE LCS PFJ TROCHLEAR COMPONENT. |
|
|