Examples of Class III medical device in a sentence
Our first product, the biocompatible scaffolding device for the treatment of acute spinal cord injury, is regulated as a Class III medical device by the FDA.
The FDA granted premarket approval for Essure, a Class III medical device, on November 4, 2002.
In addition to the definition in the act, “practicing medicine” means any person who in any manner operates or delegates the responsibility to operate a medical device classified as a Class II or Class III medical device by the U.S. Food and Drug Administration unless operation or authorization for operation occurs in a site under the direct supervision of a person licensed under this chapter.
If the FDA ultimately classifies our CryoValve SGPV as a Class III medical device, and if there are delays in obtaining the PMA, if we are unsuccessful in obtaining the PMA, or if the costs associated with these activities are significant, we could decide that the requirements for continued processing of the CryoValve SGPV are too onerous, leading us to discontinue distribution of these tissues.
Class II medical devices are subject to additional controls, including full applicability of the Quality System Regulations, and requirements for 510(k) pre-market notification.The FDA may disagree with the classification of a new Class II medical device and require the manufacturer of that device to apply for approval as a Class III medical device.
On the contrary, respondents argued that “[p]etitioners mischaracterize th[is] lawsuit as one primar- ily involving so-called ‘adverse event reports’ ” when, in fact, it involved much more detailed and corroborated information, including “complaints .
In the event that the FDA determines that our medical products should be reclassified as a Class III medical device, we could be precluded from marketing the devices for clinical use within the United States for months, years or longer, depending on the specific changes to the classification.
If the FDA finds that there is no suitable predicate medical device, it will automatically be considered our Ehave MegaTeam games or any other computerized cognitive assessment aid products that we apply for clearance to market, advertise or sell in the future a Class III medical device.
Essure is a Class III medical device that required premarket approval by the Food and Drug Administration (the “FDA”).
In addition to the definition in the act, "practicing medicine" means any person who in any manner operates or delegates the responsibility to operate a medical device classified as a Class II or Class III medical device by the U.S. Food and Drug Administration unless operation or authorization for operation occurs in a site under the direct supervision of a person licensed under this chapter.