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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 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 NumberS020
Date Received10/27/2006
Decision Date12/21/2007
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR CHANGES TO THE PACKAGE INSERT AND KIT BOX TEXT BASED ON REPORTS ASSOCIATED WITH SEVERAL TYPES OF AES. THESE AES WERE THE PRESENCE OF FLUID-FILLED CYSTS OR RADIOGRAPHIC EVIDENCE OF PERI-IMPLANT TRANSIENT BONE RESORPTION. IT?S BELIEVED THAT OVERPACKING OF THE ACS COMPONENT WITHIN A CONFINED SPACE AND/OR HYPERCONCENTRATING THE RHBMP-2 SOLUTION WERE RESPONSIBLE FOR THE AES.
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