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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 NumberS007
Date Received03/04/2004
Decision Date03/30/2004
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE PACKAGE INSERT. SPECIFICALLY, ADDING THE FOLLOWING ADDITIONAL EVENTS TO THE "POSSIBLE ADVERSE EVENTS" SECTION OF THE INSERT: "EDEMA (SWELLING), INFLAMMATION, ERYTHEMATOUS, ALLERGIC REACTION, DYSPHASIA, ITCHING, ANAPHYLACTIC REACTION, ELEVATED ERYTHROCYTE SEDIMENTATION RATE, PAIN, HEMATOMA."
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