Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel will meet 11/18 from 8 a.m. to 6 p.m. and 11/19, from 8 a.m. to 11 a.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. On 11/18, the committee will vote on a TransMedics PMA for the TransMedics Organ Care System —Heart, a portable, ex vivo organ perfusion system intended to preserve a donor heart in a near-normothermic and beating state from retrieval until the eventual transplantation into a suitable recipient.
On 11/19, the committee will discuss and make recommendations on the classification of the product code “LKX”, and the associated device classification name, “Device, Thermal, Hemorrhoids,” the classification of the product code “LRL”, and the associated device classification name, “Cushion, Hemorrhoid,” which represents a category of devices intended to temporarily relieve pain and pressure caused by hemorrhoids, and the product code “LKN”, and the associated device classification name, “Separator, automated, blood cell and plasma, therapeutic,” which represents a category of centrifuge-type devices intended to separate blood components and perform therapeutic plasma exchange for the management of serious medical conditions in adults and children. Contact Patricio G. Garcia, (301) 796-6875. To view this notice, click here.