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P000054 Wyeth Pharmaceuticals, Inc. InductOs (rhBMP-2/ACS Device)

P000054 Wyeth Pharmaceuticals, Inc. InductOs (rhBMP-2/ACS Device). Restorative Devices Branch Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health. Aric Kaiser, MS - PMA lead reviewer

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P000054 Wyeth Pharmaceuticals, Inc. InductOs (rhBMP-2/ACS Device)

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  1. P000054Wyeth Pharmaceuticals, Inc.InductOs (rhBMP-2/ACS Device) Restorative Devices Branch Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

  2. Aric Kaiser, MS - PMA lead reviewer Peter Hudson, PhD - lead preclinical reviewer Barbara Buch, MD - clinical reviewer Chang Lao, PhD - statistical reviewer Review teamPrimary review team

  3. Angel Torres-Cabassa, CDRH Martin Yahiro, CDRH Pam E Scott, CDRH Sergio Gadaleta, CDRH Erin Keith, CDRH Kevin Lee, CDRH Tracey Bourke, CDRH Nirmal Mishra, CDRH Carol Arras, CDRH Mary Ann Wollerton, CDRH Jean Toth-Allen, CDRH Josie Yang, CDER Mercedes Serabian, CBER Barbara Wilcox, CBER John Hill, CBER Gary Kikuchi, CBER Carol Rehkopf, CBER Review teamAdditional review expertise

  4. Device description • InductOs (rhBMP-2/ACS Device) • 2 component combination product • growth factor - rhBMP-2 • recombinant human bone morphogenetic protein 2 • carrier/scaffold - ACS • absorbable collagen sponge

  5. Indication for Use • studied: • acute open tibia fractures stabilized by IM nails • proposed: • "…the treatment of acute long bone fractures that require open surgical management. InductOs increases the probability of fracture healing, accelerates fracture healing, and decreases the frequency and invasiveness of interventions for delayed union or nonunion…"

  6. Submission history • Original PMA • not approvable letter issued • 2nd submission • reanalyses of original data to address not approvable issues and other deficiencies

  7. Data review • Preclinical • issues being addressed • tumor promotion • fetal development • new ELISA assays • Clinical and statistical • outstanding issues to be discussed

  8. Panel questions • Study design • Effectiveness • Safety • Labeling

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