AngioDynamics Receives FDA Clearance and CE Mark for ... | 合法醫療器材資訊網

2020年7月27日—AngioDynamicsReceivesFDAClearanceandCEMarkforSmartPort+ImplantablePort...AngioDynamics,Inc....SmartPort+isanimplantable, ...

AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced that they have received 510(k) clearance from the U.S. Food & Drug Administration (FDA), as well as a CE Mark by the European Commission, for their SmartPort+ Implantable Port.

SmartPort+ is an implantable, subcutaneous port for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids.

“We are very pleased to have received FDA clearance and a CE Mark for SmartPort+, allowing us to bring this product to patients in the United States and Europe,” said Chad Campbell, Senior Vice President and General Manager of AngioDynamics’ Global Vascular Access business unit. “SmartPort+, SmartPort Plastic, and the Port Patient App give providers and patients ...