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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(R) WITH CSTI(TM)
Generic NamePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
ApplicantSULZERMEDICA
9900 SPECTRUM DR.
AUSTIN,, TX 78717
PMA NumberP940002
Supplement NumberS002
Date Received06/17/1997
Decision Date10/16/1997
Reclassified Date 02/01/2003
Product Code MBD 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for another sterilization site located at SteriGenics International, 3125 Wichita Court, Forth Worth, Texas 76140.
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