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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
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000054
Supplement NumberS016
Date Received11/16/2007
Decision Date03/17/2008
Product Code MPW 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR INCLUSION OF A WARNING RELATED TO LOCALIZED, TRANSIENT BONE RESORPTION IN THE PACKAGE INSERT. THE INCLUSION OF THIS ADDITIONAL WARNING WAS PROMPTED BY A LABELING MODIFICATION REQUIRED BY THE EU AS A RESULT OF AN ANALYSIS OF REPORTED ADVERSE EVENTS.
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