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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 NumberS005
Date Received08/22/2003
Decision Date12/27/2004
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE DRAFT PROTOCOL FOR THE RABBIT REPRO/TOX STUDY REQUIRED AS A CONDITIONS OF APPROVAL. THE PROPOSED STUDY IS DESIGNED TO EVALUATE THE IMPACT OF A MATERNAL IMMUNE RESPONSE ON THE DEVELOPMENT OF OFFSPRING. THIS IS DETERMINED VIA AN ASSESSMENT OF "ETAL MORTALITY, FETAL WEIGHT, AND FETAL PLACENTAL MORPHOLOGY
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