Atlas FDA

Guardian Connect System

FDA premarket approval P160007/S025 · decided 2019-08-26

Approval details

PMA number
P160007
Supplement
S025
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Guardian Connect System
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2019-08-21
Decision date
2019-08-26
Days to decision
5 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Addition of new sterilization equipment at two previously approved sterilization facilities for the sterilization of the Enlite and Guardian Sensor (3) continuous glucose monitoring sensors. The Enlite sensor is a component of the MiniMed 530G system, the MiniMed 630G system, the Paradigm Real-Time Revel system, and the iPro2 with Enlite sensor system. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system.

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510(k) clearances by this applicant

RecordFirmDate
SmartGuard Technology; Predictive Low Glucose Technology (K261962)Medtronic MiniMed2026-07-09
SmartGuard Technology; Predictive Low Glucose Technology (K253701)Medtronic Minimed2026-02-03
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Extended Reservoir; MiniMed Reservoir (K241622)Medtronic Minimed2024-07-02
MiniMed Quick-serter (K160860)Medtronic Minimed2016-09-22
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206)Medtronic Minimed2012-03-29
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432)Medtronic Minimed2010-07-09