Guardian Connect system
FDA premarket approval P160007 · decided 2018-03-08
Approval details
- PMA number
- P160007
- Trade name
- Guardian Connect system
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2016-03-08
- Decision date
- 2018-03-08
- Days to decision
- 730 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- 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 Con
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510(k) clearances by this applicant
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|---|---|---|
| SmartGuard Technology; Predictive Low Glucose Technology (K261962) | Medtronic MiniMed | 2026-07-09 |
| SmartGuard Technology; Predictive Low Glucose Technology (K253701) | Medtronic Minimed | 2026-02-03 |
| MiniMed Go App (K253512) | Medtronic Minimed | 2026-01-08 |
| InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (K242775) | Medtronic Minimed | 2024-11-12 |
| Extended Reservoir; MiniMed Reservoir (K241622) | Medtronic Minimed | 2024-07-02 |
| MiniMed Quick-serter (K160860) | Medtronic Minimed | 2016-09-22 |
| MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206) | Medtronic Minimed | 2012-03-29 |
| POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432) | Medtronic Minimed | 2010-07-09 |