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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.
 
DeviceNATURAL KNEE & NATURAL KNEE II
Generic NamePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
ApplicantSULZERMEDICA
9900 SPECTRUM DR.
AUSTIN,, TX 78717
PMA NumberP940002
Supplement NumberS003
Date Received03/24/2000
Decision Date04/18/2000
Reclassified Date 02/01/2003
Product Code MBD 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for use of forged Ti alloy as a material for the construction of the stemmed tibial base plate component of the devices.
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