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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceGuardian Connect system
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP160007
Date Received03/08/2016
Decision Date03/08/2018
Product Code MDS 
Docket Number 18M-1371
Notice Date 04/10/2018
Advisory Committee Clinical Chemistry
Clinical Trials NCT02246582
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the Guardian Connect system.The Guardian Connect system is indicated for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in patients (14 to 75 years of age) with diabetes mellitus. The Guardian Connect system provides real-time glucose values and trends through a Guardian Connect app installed on a compatible consumer electronic mobile device. It allows users to detect trends and track patterns in glucose concentrations. The Guardian Connect app alerts if a Guardian Sensor (3) glucose level reaches, falls below, rises above, or is predicted to surpass set values. The Guardian Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the Guardian Sensor (3).The Guardian Connect system is comprised of the following devices: Guardian Connect app, Guardian Sensor (3), and the Guardian Connect transmitter.Guardian Sensor (3):The Guardian Sensor (3) is intended for use with Medtronic Diabetes glucose-sensing systems, to continuously monitor glucose levels in persons with diabetes. The Guardian Sensor (3) is indicated for 7 days of continuous use. It is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices. The sensor is intended for single use and requires a prescription. Guardian Connect Transmitter:The Guardian Connect transmitter is intended for use with the Guardian Connect system. The Guardian Connect transmitter powers the glucose sensor, collects and calculates sensor data, and sends the data via Bluetooth version 4.0 to the Guardian Connect app installed on a compatible mobile device. The transmitter is only compatible with the Guardian Sensor (3). The transmitter is indicated for multiple uses on a single patient as a component of the Guardian Connect system.The Guardian Connect transmitter requires a prescription. Guardian Connect App:The Guardian Connect app is intended for use only by patients using a compatible mobile device, and who have sufficient experience to adjust mobile device audio and notification settings. The app displays sensor glucose data, and also provides a user interface for sensor calibration, entering data such as exercise and meals, and uploading information to the CareLink Personal website. It allows users to detect trends and track patterns in glucose concentrations. The Guardian Connect app provides alerts if a Guardian Sensor (3) glucose level reaches, falls below, rises above, or is predicted to surpass set values.The Guardian Connect app is available over-the-counter (OTC) but requires the Guardian Sensor (3) and Guardian Connect transmitter to function.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 S010 S011 S013 S015 S016 S017 S020 S021 
S022 S023 S024 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S036 S037 
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