Simplera Sync Sensor, Guardian 4 Sensor
PMA P250012
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP250012 | Date6 Aug 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic name
- Sensor, Glucose, Invasive, Component of automated insulin delivery system
- PMA number
- FDA product code
- SFI
- Device class
- Class III
- Advisory committee
- Clinical Chemistry
- FDA decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Simplera Sync Sensor and Guardian 4 Sensor are invasive glucose sensors intended to function as components of a Medtronic automated insulin dosing system. They are designed to continuously monitor glucose levels in interstitial fluid to support automated insulin delivery.
These sensors are supplied as sterile, single-use components for use in clinical and home settings under the direction of a healthcare provider. They are not MRI safe unless explicitly stated in labeling, and storage conditions must follow manufacturer specifications. Authorization is based on FDA PMA P250012, with no additional claims made beyond the approved indications.
Other devices from Medtronic Minimed, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary function of the Simplera Sync Sensor and Guardian 4 Sensor?
The Simplera Sync Sensor and Guardian 4 Sensor are invasive glucose sensors designed to continuously monitor glucose levels in interstitial fluid. They function as components of Medtronic's automated insulin dosing system, providing real-time data to support insulin delivery decisions.
Are the Simplera Sync Sensor and Guardian 4 Sensor reusable or single-use?
The Simplera Sync Sensor and Guardian 4 Sensor are supplied as sterile, single-use components. They are intended for one-time use only and must be discarded after each application according to the manufacturer's instructions for use.
What regulatory authorization covers the Simplera Sync Sensor and Guardian 4 Sensor?
The Simplera Sync Sensor and Guardian 4 Sensor are authorized under FDA Premarket Approval (PMA) P250012. This approval was granted on August 6, 2025, for their use as components of a Medtronic automated insulin delivery system.