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PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSULIN PUMP

FDA premarket approval P980022/S176 · decided 2015-08-25

Approval details

PMA number
P980022
Supplement
S176
Supplement type
Normal 180 Day Track
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
2015-02-17
Decision date
2015-08-25
Days to decision
189 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR DESIGN AND MANUFACTURING CHANGES TO THE DSCAP AND CASE BOTTOM TO INCLUDE A METRIC THREAD INTERFACE FOR THE PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODEL NUMBERS MMT-522, 522K, 523, 523K, 722, 722K, 723, 723K), AND MINIMED 530G INSULIN PUMPS (MODEL NUMBERS MMT-551, 751), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THEMINIMED 530G SYSTEM.

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510(k) clearances by this applicant

RecordFirmDate
SmartGuard Technology; Predictive Low Glucose Technology (K261962)Medtronic MiniMed2026-07-09
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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