FDA Hearing: Orthopaedic Devices Panel
CONCLUDED
Hearing
05/12/11 – 05/12/11
Summary
Application for the premarket approval of Augment Bone Graft (Biomimetic).
On May 12, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc. The intended use of the device is as an alternative bone grafting substitute to autologous bone graft in applications to facilitate fusion in the ankle and foot without necessitating an additional invasive procedure to harvest the graft.
- Plaintiff
- Defense
- Jurisdiction
- Food and Drug Administration
- Court
- FDA Panel (Hilton Hotel)
- Industry
- Pharmaceutical
- Practice Area
- Health Law
- Expert Witnesses
- Lay Witnesses
Sessions
AM Session
Other
4 Chapters
| Description | Attorney | Witness | Presence | |||
|---|---|---|---|---|---|---|
 | 00:00:00 | General Case Activities | ||||
| 01:28:29 | Break | ||||
| 01:43:10 | General Case Activities | ||||
| 03:31:28 | End of Session |
PM Session
Other
4 Chapters
Recording Disclaimer: This proceeding was recorded in full.