We ran across this article in Fierce Medical Devices and thought we would share it. The article highlights the Top 10 device and diagnostic approvals for 2012. Every year companies submit their Premarket Approval Application (PMA), the application submitted to the FDA for approval of a Class III device, to FDA seeking premarket approval. This application can sometimes prompt FDA to inspect clinical sites, but ultimately the hope for a sponsor is approval.
Topics: Top 10, FDA Approvals, Device and Diagnostics