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PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM

FDA premarket approval P980022/S021 · decided 2008-04-18

Approval details

PMA number
P980022
Supplement
S021
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2007-10-24
Decision date
2008-04-18
Days to decision
177 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR AN OPTIONAL CAPABILITY OF AUTOMATICALLY DOWNLOADING GLUCOSE RESULTS FROM THE LIFESCAN ONETOUCH ULTRALINK BLOOD GLUCOSE METER IN ADDITION TO THE CURRENT BD PARADIGM LINK GLUCOSE METER. THIS MODIFICATION INCLUDES AN OPTIONAL CAPABILITY FOR THE MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMPS OR THE GUARDIAN REAL-TIME GLUCOSE MONITOR TO RECEIVE BLOOD GLUCOSE VALUES AUTOMATICALLY TRANSMITTED BY A LIFESCAN ONETOUCH ULTRALINK BLOOD GLUCOSE METER. THE GUARDIAN? REAL-TIME SYSTEM IS INDICAT

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510(k) clearances by this applicant

RecordFirmDate
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MiniMed Quick-serter (K160860)Medtronic Minimed2016-09-22
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206)Medtronic Minimed2012-03-29
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