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PRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR

FDA premarket approval P980022/S116 · decided 2012-05-24

Approval details

PMA number
P980022
Supplement
S116
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2012-03-26
Decision date
2012-05-24
Days to decision
59 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL OF A CHANGE OF THE FIELD EFFECT TRANSISTOR (FET), A COMPONENTOF THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-723, MMT-523K, MMT-723K), THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-722, MMT-522K, MMT-722K), AND THE GUARDIAN REAL-TIME MONITOR (MODELS CSS7100 AND CSS7100K), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME AND GUARDIAN REAL-TIME SYSTEMS.

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510(k) clearances by this applicant

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