Skip to content

Guardian Sensor (3)

by Medtronic Minimed

PMA P160007

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

PMA P160007↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP160007 Date8 Mar 2018ApprovedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-0033-2026 FDA Class II initiated 7 May 2025

    The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

    • Ongoing Z-2106-2020 FDA Class II initiated 20 May 2019

    Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.

    • Terminated Z-1282-2019 FDA Class II initiated 4 Jul 2018

    The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade name
Guardian Connect system
Generic name
Sensor, glucose, invasive
PMA number
FDA product code
MDS
Device class
Class III
Advisory committee
Clinical Chemistry
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Guardian Sensor (3) is a Sensor, glucose, invasive (per FDA nomenclature), designed for continuous or periodic monitoring of interstitial glucose levels in patients aged 14 to 75 with diabetes mellitus. It provides real-time glucose readings and trends via a paired transmitter and mobile app, serving as an adjunctive tool to standard blood glucose monitoring rather than a replacement for therapy adjustments.

The Guardian Sensor (3) is intended for single-use over 7 days and requires a prescription. It operates as part of the Guardian Connect system, which includes a Bluetooth-enabled transmitter (compatible only with this sensor) and a mobile app for data visualization, alerts, and user inputs like meal/exercise tracking. The device is not MRI-safe and must be stored as specified by Medtronic Minimed. Authorization for this device was granted under FDA_PMA (P160007).

Other devices from Medtronic Minimed, Inc.

See all devices from Medtronic Minimed, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Guardian Sensor (3) used for?

    The Guardian Sensor (3) is designed for continuous or periodic monitoring of interstitial glucose levels in patients aged 14 to 75 with diabetes mellitus. It serves as an adjunctive tool to standard blood glucose monitoring rather than a replacement for therapy adjustments.

  • How long can the Guardian Sensor (3) be used?

    The Guardian Sensor (3) is intended for single-use over 7 days. It must be replaced after this period, and therapy adjustments should be based on measurements from standard blood glucose monitors, not the sensor values.

  • What components are included in the Guardian Connect system?

    The Guardian Connect system includes the Guardian Sensor (3), a Bluetooth-enabled transmitter (compatible only with this sensor), and a mobile app for data visualization, alerts, and user inputs like meal and exercise tracking.

  • Is the Guardian Sensor (3) MRI-safe?

    No, the Guardian Sensor (3) is not MRI-safe. Patients should follow specific storage instructions provided by Medtronic Minimed to maintain the device's integrity and functionality.

  • What is the regulatory status of the Guardian Sensor (3)?

    The Guardian Sensor (3) received FDA approval under PMA number P160007. It is part of the Guardian Connect system, which is indicated for continuous or periodic monitoring of glucose levels in patients aged 14 to 75 with diabetes mellitus.