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. |
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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 | S011 |
Date Received | 04/09/1998 |
Decision Date | 03/04/1999 |
Withdrawal Date
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04/18/2012 |
Product Code |
MBD |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a sterilization site located at DePuy International Ltd., St. Anthony's Road, Leeds LS11 8DT, England. |
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