DevicePMAs@therightstef:P020024_S005 JSONTXT

Approval for changes to the labeling to support compatibility of the devices with MR environments up to 3.0 Tesla. The device, as modified, will be marketed under the trade name AMPLATZER Duct Occluder Device with the following indications for use: The AMPLATZER Duct Occluder Device is indicated for the non-surgical closure of patent ductus arteriosus (PDA).