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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
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 pyramid place
memphis, TN 38132
PMA NumberP000058
Supplement NumberS006
Date Received08/26/2003
Decision Date09/17/2003
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR A RETRIEVED IMPLANT PROTOCOL USED TO OBTAIN DATA TO COMPLY WITH ONE OF THE CONDITIONS OF APPROVAL.
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