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PARADIGM REAL TIME PUMP & PARADIGM REAL TIME REVEL INSULIN PUMP

FDA premarket approval P980022/S138 · decided 2013-10-31

Approval details

PMA number
P980022
Supplement
S138
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
PARADIGM REAL TIME PUMP & PARADIGM REAL TIME REVEL INSULIN PUMP
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2013-10-03
Decision date
2013-10-31
Days to decision
28 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL OF LABELING CHANGES TO THE USER GUIDE FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, AND MMT-722K), AND FOR THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-523K, MMT-723, AND MMT-723K). THE PARADIGM REAL-TIME INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEMS.

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