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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.
 
DeviceMedtronic MiniMed 670G System
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMEDTRONIC MINIMED, INC.
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325
PMA NumberP160017
Supplement NumberS074
Date Received10/11/2019
Decision Date11/04/2019
Product Code OZP 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Packaging, labeling, and final release activities of the One-Press Serter conducted at Medtronic, Inc. to be moved to contract manufacturer facility. The One-Press Serter is a component of the 530G System, the 630G System, the 670G System, and the Guardian Connect System.
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