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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.
 
DeviceATTUNE Revision Femoral Sleeves
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantDepuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581
PMA NumberP830055
Supplement NumberS206
Date Received08/21/2018
Decision Date09/20/2018
Product Code NJL 
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 an increase in the inspection frequency of the overall height dimension performed at the vendor site(Tecomet), and for the addition of the overall height dimension check at the receiving inspection at the finished goods manufacturing site (DePuy Warsaw).
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