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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 NumberS034
Date Received09/01/2009
Decision Date01/14/2010
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE REMOVAL OF ELLMAN¿S ASSAY AND SDS-PAGE SILVER STAIN TESTS FROM THE RHBMP-2 DRUG SUBSTANCE RELEASE SPECIFICATION.
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