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PARADIGM REAL-TIME INSULIN PUMPS;PARADIGM REAL-TIME REVEL INSULIN PUMPS

FDA premarket approval P980022/S133 · decided 2014-01-15

Approval details

PMA number
P980022
Supplement
S133
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PARADIGM REAL-TIME INSULIN PUMPS;PARADIGM REAL-TIME REVEL INSULIN PUMPS
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2013-02-22
Decision date
2014-01-15
Days to decision
327 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR THE REDUCTION OF KEYPAD BUTTON (DOME) SIZES, NEW KEYPAD OVERLAY SUPPLIER (BERGQUIST), AND KEYPAD/ OVERLAY/ CASE ASSEMBLY PROCESS FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS: MMT-522, MMT-522K, MMT-722, MMT-722K AND PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS: MMT-523, MMT-523K, MMT-723, AND MMT-723K) THAT ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL 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
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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