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PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM, GUARDIAN REAL TIME SYSTEM

FDA premarket approval P980022/S179 · decided 2016-01-21

Approval details

PMA number
P980022
Supplement
S179
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM, GUARDIAN REAL TIME SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2015-03-10
Decision date
2016-01-21
Days to decision
317 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR THE ADDITION OF A NEW LEAK TESTER TO THE MANUFACTURING PROCESS OF THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, 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