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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.
 
DeviceGuardian Connect System
Generic Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP160007
Supplement NumberS037
Date Received08/04/2020
Decision Date09/02/2020
Product Code MDS 
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  
IntriCon Corporation (IntriCon Red Fox), 1260 Red Fox Road, Saint Paul, MN as an alternative finished product manufacturing facility and IntriCon Corporation Grey Fox (IntriCon Grey Fox), 1275 Grey Fox Road Arden Hills, MN as an alternate final packaging process facility for the Guardian Link (3) and Guardian Connect Transmitter. The transmitters are components of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System. The submission also requested approval of process changes related to the new manufacturing facilities including a new inspection process and equipment.
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