Premarket haloperidol adverse effects Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an haloperidol adverse effects up-to-date information on device changes. The labeling included below is the version at time of haloperidol adverse effects approval of the original PMA or panel track supplement and haloperidol adverse effects may not represent the most recent labeling.

MiniMed 670G systemthe medtronic minimed 670G system is intended for haloperidol adverse effects continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons, fourteen years of age and older, requiring insulin as well as for the continuous monitoring and haloperidol adverse effects trending of glucose levels in the fluid under the skin. The minimed 670G system includes smartguard technology, which can be programmed to automatically adjust delivery of basal haloperidol adverse effects insulin based on continuous glucose monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose haloperidol adverse effects value falls below or is predicted to fall below predefined haloperidol adverse effects threshold values.The medtronic minimed 670G system consists of the following devices: minimed 670G insulin pump, the guardian link (3) transmitter, the guardian sensor (3), one-press serter, and the contour NEXT link 2.4 glucose meter. The system requires a prescription.The guardian sensor (3) glucose values are not intended to be used directly for haloperidol adverse effects making therapy adjustments, but rather to provide an indication of when a finger haloperidol adverse effects stick may be required. All therapy adjustments should be based on measurements obtained using haloperidol adverse effects a home glucose monitor and not on values provided by haloperidol adverse effects the guardian sensor (3).Guardian sensor (3)the guardian sensor (3) is intended for use with the minimed 670G system to haloperidol adverse effects continuously monitor glucose levels in persons with diabetes. It is intended to be used for detecting trends and haloperidol adverse effects tracking patterns in persons aged fourteen years and older, and to be used by the minimed 670G system to haloperidol adverse effects automatically adjust basal insulin levels. It is indicated for use as an adjunctive device to haloperidol adverse effects complement, not replace, information obtained from standard blood glucose monitoring devices. The sensor is intended for single use and requires a haloperidol adverse effects prescription. The guardian sensor (3) is indicated for 7 days of continuous use.One-press serterthe one-press serter is used as an aid for inserting the haloperidol adverse effects sensor. It is indicated for single-patient use and it is not intended for multiple-patient use.Guardian link (3) transmitter the guardian link (3) transmitter is intended for use with the minimed 670G system. The guardian link (3) transmitter powers the glucose sensor, collects and calculates sensor data, and wirelessly sends the data to the minimed 670G insulin haloperidol adverse effects pump. The transmitter is intended for single-patient multi-use. Contour NEXT link 2.4 glucose meterthe contour next link 2.4 wireless blood glucose monitoring system is an over the haloperidol adverse effects counter (OTC) device utilized by persons with diabetes in home settings for haloperidol adverse effects the measurement of glucose in whole blood, and is for single patient use only and should not haloperidol adverse effects be shared. The contour next link 2.4 wireless blood glucose monitoring system is indicated for use haloperidol adverse effects with fresh capillary whole blood samples drawn from the fingertip haloperidol adverse effects and palm only. The contour NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of haloperidol adverse effects glucose in whole blood samples from 20 to 600 mg/dl. The contour next link 2.4 wireless blood glucose monitoring system is intended to be haloperidol adverse effects used to transmit glucose values to the minimed 670G pump haloperidol adverse effects and facilitate transfer of information to medtronic carelink software through haloperidol adverse effects the use of radio frequency communication. The contour next link 2.4 wireless blood glucose monitoring system is not intended for haloperidol adverse effects the diagnosis of, or screening for, diabetes mellitus. It is not intended for use on neonates.

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