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. |
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Device | INFUSE BONE GRAFT |
Generic Name | Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P000054 |
Supplement Number | S002 |
Date Received | 08/02/2004 |
Decision Date | 08/09/2004 |
Product Code |
MPW |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR EXPANSION OF THE UPPER END OF THE STORAGE TEMPERATURE LIMIT FOR THE INFUSE BONE GRAFT COMPONENT OF THE DEVICE FROM 25 DEGREES C TO 30 DEGREES C. THE DEVICE IS INDICATED FOR TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT. INFUSE BONE GRAFT MUST BE APPLIED WITHIN 14 DAYS AFTER THE INITIAL FRACTURE. PROSPECTIVE PATIENTS SHOULD BE SKELETALLY MATURE. |
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