August 25, 2011 – The U.S. Food and Drug Administration (FDA) has released its list of pre-market approval (PMA) and 510(k) decisions for new or enhanced medical devices from June 2011. The list includes all FDA PMAs, product development protocols (PDP), supplement and notice decisions. This list is generated on a monthly basis.
PMAs are granted for new devices and 510(k) approvals are granted for device’s cleared commercialization that are substantially similar to a previously FDA cleared device.
For the list of new 510(k) decisions: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm268590.htm