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 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 | S091 |
Date Received | 08/29/2005 |
Decision Date | 09/12/2005 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE CRITERIA USED IN THE MANUFACTURE OF THE REFERENCED COMPONENTS. THIS MODIFICATION ADDS A STEP TO THE INSPECTION PROCEDURE BY UTILIZING A GAGE TO AID IN THE INSPECTION OF THE SPIRALOCK TAPPED HOLE PRIOR TO TAPPING. |
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