Related Experiment Video
Updated: Mar 11, 2026
23:33
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
84.7K
Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device. Final order
Federal Register
|December 3, 2016
Abstract:
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.
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