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

FDA premarket approval P980022/S165 · decided 2014-11-26

Approval details

PMA number
P980022
Supplement
S165
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2014-10-27
Decision date
2014-11-26
Days to decision
30 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
CHANGE FROM A MANUAL PROCESS TO A SEMI-AUTOMATED PROCESS FOR A TEST CARRIEDOUT DURING ACCEPTANCE TESTING OF THE PARADIGM® REAL-TIME INSULIN PUMP (MODELS: MMT-522,MMT-522K, MMT-722, MMT-722K); PARADIGM® REAL-TIME REVEL INSULIN PUMP (MODELS:MMT-523, MMT-523K, MMT-723, MMT-723K); MINIMED 530G INSULIN PUMP (MODELS:MMT-551, MMT-751) CASES. THE PARADIGM® REAL-TIME, PARADIGM® REAL-TIME REVEL, ANDMINIMED 530G INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM® REAL-TIME SYSTEM,PARADIGM® REAL-TIME REVEL SYSTEM

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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