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(R)TOTAL KNEE SYSTEM |
Generic Name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581-0988 |
PMA Number | P910016 |
Supplement Number | S010 |
Date Received | 12/15/1997 |
Decision Date | 01/15/1998 |
Withdrawal Date
|
04/18/2012 |
Product Code |
MBD |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of multilingual package labeling and a multilingual package insert for the components of the Unicompartmental Configuration of the LCS(R) Total Knee System. |
|
|