FDA Panel To Review Zimmer PMA For Dynesys Spine Stabilization System
This article was originally published in The Gray Sheet
Zimmer will argue for PMA approval of its Dynesys dynamic spinal stabilization device Nov. 4 in front of FDA's Orthopaedic and Rehabilitation Devices panel
You may also be interested in...
FDA is ordering 12 spine device manufacturers to begin collecting post-market data on how well their devices fare in doing what they are 510(k)-cleared to do: support spinal fusion procedures
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.