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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 Insulin Pump Guardian Link (3) Transmitter
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMEDTRONIC MINIMED, INC.
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325
PMA NumberP160017
Supplement NumberS048
Date Received07/23/2018
Decision Date11/20/2018
Product Code OZP 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for updating the transmitter firmware to improve user experience and to correct various software anomalies.
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