Over a medical device’s lifetime the amount of information regarding its safety and effectiveness will increase and can possibly reduce the risk associated with the device. If this happens there is a reclassification process that can be used to update the class of the device type based on current information. The type of the device being changed from class III to class II, for example, would allow devices of the same type created after that device to be also classified as class II if they are shown to be substantially equivalent. The fact that a device must be “substantially equivalent” protects against less safe devices being classified under the same type. The device stop gap is a type of LAA closure device and was classified as a class II, through the De Novo process, because the general and special controls for LAA Closure devices have shown reasonable assurance of safety and effectiveness for their intended use. Further, regulatory and quality controls will ideally prevent an unsafe product from being on the market.