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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMiniMed 670G System
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMEDTRONIC MINIMED, INC.
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325
PMA NumberP160017
Supplement NumberS018
Date Received08/04/2017
Decision Date10/31/2017
Product Code OZP 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for design changes to the Contour Next Link 2.4 Wireless Blood Glucose Meter. The Contour Next Link 2.4 Wireless Blood Glucose Meter is a component of the Medtronic MiniMed 630G System and Medtronic MiniMed 670G System.
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