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PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP

FDA premarket approval P980022/S177 · decided 2016-01-22

Approval details

PMA number
P980022
Supplement
S177
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2014-12-30
Decision date
2016-01-22
Days to decision
388 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR THE ADDITION OF AN ANNEALING PROCESS AND CHEMICAL EXPOSURE DURABILITY TEST FOR THE SMOKE COLOR IN THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-753, MMT-753K) AND MINIMED 530G INSULIN PUMPS (MMT-751). THESE ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL AND MINIMED 530G SYSTEMS, RESPECTIVELY.

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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