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 | S040 |
Date Received | 10/25/2013 |
Decision Date | 12/06/2013 |
Product Code |
MPW |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR EXTENSION OF THE RHBMP-2 DRUG SUBSTANCE EXPIRATION DATE FROM 60 TO 72 MONTHS USING THE APPROVED EXPIRATION DATE MODIFICATION PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE®BONE GRAFT AND IS INDICATED FOR THE FOLLOWING: 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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