Atlas FDA

CGMS IPRO SYSTEM

FDA premarket approval P980022/S020 · decided 2008-01-22

Approval details

PMA number
P980022
Supplement
S020
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
CGMS IPRO SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2007-06-19
Decision date
2008-01-22
Days to decision
217 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR THE CGMS IPRO SYSTEM. THE CGMS IPRO SYSTEM INCLUDES THE CGMS IPRO DIGITAL RECORDER, SOLUTIONS SOFTWARE FOR CGMS IPRO, COMLINK IPRO, AND CGMS IPRO WAND. THE DEVICE IS INTENDED TO CONTINUOUSLY RECORD INTERSTITIAL GLUCOSE LEVELS IN PERSONS WITH DIABETES MELLITUS. THE INFORMATION IS INTENDED TO SUPPLEMENT, NOT REPLACE, BLOOD GLUCOSE INFORMATION OBTAINED USING A STANDARD HOME GLUCOSE-MONITORING DEVICE. THE INFORMATION COLLECTED BY THE CGMS IPRO DIGITAL RECORDER MAY BE DOWNLOADED, USING T

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