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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.
 
DeviceDURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantDEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988
PMA NumberP040023
Supplement NumberS002
Date Received11/10/2005
Decision Date12/12/2005
Withdrawal Date 04/03/2014
Product Code MRA 
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 CHANGES IN QUALITY CONTROLS TO VARIOUS COMPONENTS OF THIS SYSTEM. THESE CHANGES INCLUDE MODIFICATION TO SEVERAL MANUFACTURING PROCESS SPECIFICATIONS (MPS) FOR GAMMA VACUUM FOIL (GVF) PACKAGED PRODUCTS: 1) TO ADD PHYSICAL SEPARATION BARRIERS TO THE SEALING MACHINE TO PREVENT ADJACENT FOIL POUCHES FROM OVERLAPPING DURING THE SEALING OPERATION, AND 2) TO REQUIRE A SECOND 100% INSPECTION OF THE SEAL INTEGRITY OF EACH PACKAGE PRIOR TO SHIPMENT.
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