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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 Pl.
Memphis, TN 38132
PMA NumberP000058
Supplement NumberS048
Date Received10/20/2011
Decision Date07/17/2012
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE IDENTIFIED PRODUCTS.SPECIFICALLY REQUESTED WAS THE FOLLOWING: 1) AN ADDITIONAL WARNING TO ADDRESS CONCERNS RELATED TO THE USE OF POTENTIAL PATIENTS WITH A SUSPECTED MALIGNANCY; 2) AN ADDITIONAL WARNING RELATED TO DEVICE MIGRATION; 3) A MODIFICATION TO THE PRECAUTION RELATED TO ECTOPIC, HETEROTOPIC AND EXUBERANT BONE FORMATION BY REMOVING THE INITIAL QUALIFYING LANGUAGE: AND 4) A MODIFICATION TO THE DESCRIPTION OF THE RECONSTITUTED RECOMBINANT PROTEIN SOLUTION, I.E., "...COLORLESS TO SLIGHTLY YELLOW..."
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