Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device. Final order.

The Food and Drug Administration (FDA) is classifying the apical closure device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the apical closure device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.