|
Device | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE |
Generic Name | Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P000058 |
Supplement Number | S005 |
Date Received | 08/22/2003 |
Decision Date | 12/27/2004 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE DRAFT PROTOCOL FOR THE RABBIT REPRO/TOX STUDY REQUIRED AS A CONDITIONS OF APPROVAL. THE PROPOSED STUDY IS DESIGNED TO EVALUATE THE IMPACT OF A MATERNAL IMMUNE RESPONSE ON THE DEVELOPMENT OF OFFSPRING. THIS IS DETERMINED VIA AN ASSESSMENT OF "ETAL MORTALITY, FETAL WEIGHT, AND FETAL PLACENTAL MORPHOLOGY |