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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 NumberS010
Date Received05/20/2004
Decision Date06/10/2004
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
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 1) AN INCREASE IN THE EXPIRATION DATE OF THE 4.2 AND 12 MG VIALED RHBMP-2 COMPONENT OF THE REFERENCED DEVICES FROM 36 TO 48 MONTHS; 2) AN INCREASE IN THE EXPIRATION DATE OF THE COMMERCIAL KIT COMPONENT FROM 24 TO 36 MONTHS; AND 3) THE PROTOCOL TO BE FOLLOWED FOR ALL FUTURE EXPIRATION DATE CHANGES.
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