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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 AND 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 NumberS005
Date Received07/12/2001
Decision Date08/01/2001
Reclassified Date02/01/2003
Product Code MBD 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS TO FURTHER ASSURE THE CLEANLINESS OF THE DEVICES.
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