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 | S133 |
Date Received | 03/14/2013 |
Decision Date | 04/12/2013 |
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 AN ADDITIONAL INSPECTION STEP AFTER THE IN PROCESS CLEAN (IPC). THE INSPECTION WILL ENSURE THAT THERE WILL BE NO REMAINING POLISHING AGENTS LEFT ON THE ATTUNE CR AND ATTUNE PS FEMORAL COMPONENTS AFTER THE IPC STEP IS PERFORMED. THE ATTUNE CR AND ATTUNE PS FEMORAL COMPONENTS WERE PREVIOUSLY APPROVED AS COMPATIBLE COMPONENTS TO THE CLASS III ROTATING PLATFORM ATTUNE TIBIAL COMPONENTS. |
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