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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.
 
DeviceINFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000058
Supplement NumberS003
Date Received12/16/2002
Decision Date06/24/2003
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR ASSEMBLING AND PACKAGING THE PARTS OF THE INFUSE BONE GRAFT COMPONENT OF THE DEVICE. THE FACILITY IS LOCATED AT MEDTRONIC SOFAMOR DANEK USA, INC., MEMPHIS, TENNESEE.
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