Medirex, Inc.; Premarket Approval of the Tripter-X1 Series Extracorporeal Shock Wave Lithotripters (Tripter-X1, Tripter-X1 Nova, and Tripter-X1 Compact)

概要

The Food and Drug Administration (FDA) is announcing its approval of the application by Medirex, Inc., Wellesley Hills, MA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Tripter-X1 Series Extracorporeal Shock Wave Lithotripters (Tripter-X1, Tripter-X1 Nova, and Tripter-X1 Compact). FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 20, 1996, of the approval of the application.