Atlas FDA

Paradigm Real-Time Revel System

FDA premarket approval P150019/S043 · decided 2018-06-28

Approval details

PMA number
P150019
Supplement
S043
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Paradigm Real-Time Revel System
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2018-06-07
Decision date
2018-06-28
Days to decision
21 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Approval for the addition of two 100% visual inspections to the needle hub assembly used in the Guardian Sensor (3) and Enlite Glucose Sensor. The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System. The Enlite Sensor is a component of the MiniMed 530G System, Paradigm Real-Time Revel System, MiniMed 630G System With SmartGuard, and MiniMed iPro2 CGM System with Enlite Sensor.

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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
MiniMed Go App (K253512)Medtronic Minimed2026-01-08
InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (K242775)Medtronic Minimed2024-11-12
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