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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Generic Nameinvertebral lumbar device
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
PMA NumberP000058
Supplement NumberS005
Date Received08/22/2003
Decision Date12/27/2004
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product Yes
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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