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PARADIGM REAL-TIME REVEL INSULIN SYSTEM

FDA premarket approval P150019/S018 · decided 2016-08-25

Approval details

PMA number
P150019
Supplement
S018
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PARADIGM REAL-TIME REVEL INSULIN SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2016-07-26
Decision date
2016-08-25
Days to decision
30 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Add a new testing station to conduct a Manual Bolus Time Test (BTT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps. These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico.

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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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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