DevicePMAs@therightstef:P980016_S492 JSONTXT 11 Projects

Approval for the mycarelink smart monitor used with the device. The device, as modified, will be marketed under the trade name mycarelink smart monitor andthe mycarelink heart application and is indicated for: patient reader indications for use: the patient reader is a portable electronic device that communicates with your medtronicimplanted heart device. the application on smart phone or tablet transmits implanted heartdevice data to the medtronic carelink network. Mobile application indications for use: the medtronic mycarelink heart application transmits implanted heart device data to the carelink network via a mobile device.