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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceUNICOMPARTMENTAL DEVICE CONFIGURATION OF THE LCS TOTAL KNEE SYSTEM
Classification Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Generic Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Applicant
DEPUY, INC.
700 orthopaedic dr.
warsaw, IN 46581-0988
PMA NumberP910016
Supplement NumberS014
Date Received05/23/2005
Decision Date09/26/2005
Product Code
MBD[ Registered Establishments with MBD ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE POST-APPROVAL STUDY.
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