The U.S. Food and Drug Administration today approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient's cornea after cataract surgery with intraocular lens placement in adults. Prior to today's ...
Tags: Gel for Sealing Corneal Incision, First Gel After Cataract Surgery
US medical device company TriVascular has commenced the US Post-Approval Study (PAS) of the Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). The Ovation System and the Ovation Prime System ...
Tags: TriVascular, medical device
The AtriCure has obtained the US Food and Drug Administration (FDA) clearance to commence three-year Ablate post approval study (PAS), designed for the surgical correction of atrial fibrillation. The 350 patient study is designed to ...
Tags: AtriCure, FDA clearance, post approval study, PAS, Synergy ablation system
Dune Medical Devices has obtained an approvable letter related to its premarket approval application (PMA) for the breast cancer detection system from the US Food and Drug Administration (FDA). The letter indicates that the system's PMA ...