美国食品和药物管理局已经审查了Implantica AG申请的第一模块,该模块是针对抗反流装置RefluxStopTM. The FDA has reviewed the first module of Implantica AG's application for RefluxStop™, an anti-reflux device.

美国食品和药物管理局已经接受并完成了对Implantica AG针对RefluxStopTM的PMA申请的第1模块的审查,该设备旨在治疗酸性反流. The FDA has accepted and completed its review of Module 1 of Implantica AG's PMA application for RefluxStop™, a device aimed at treating acid reflux. 该模块包括质量系统和制造细节。 This module included quality systems and manufacturing details. 在最终批准之前,FDA将检查生产地点以确保合规. Before final approval, the FDA will inspect production sites to ensure compliance. 已经在欧洲指定为CE的RfulstopTM, 旨在将抗回流治疗方案革命化。 RefluxStop™, already CE-marked in Europe, aims to revolutionize anti-reflux treatment options.