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PARADIGM REAL-TIME REVEL SYSTEM

FDA premarket approval P150019/S008 · decided 2016-03-23

Approval details

PMA number
P150019
Supplement
S008
Supplement type
30-Day Notice
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
2016-02-23
Decision date
2016-03-23
Days to decision
29 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Manufacturing facility move by Medtronic’s Enlite sensor substrate supplier. The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor. The sensor substrate supplier, Metrigraphics, LLC, currently manufactures the Enlite sensor substrate in Wilmington, Massachusetts and will start manufacturing at the new facility in Lowell, Massachusetts. The firm states that the current sensor substrate manufacturing facility will close at the end of

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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
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