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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 630G System
Generic Nameautomated insulin dosing , threshold suspend
18000 devonshire st
northridge, CA 91325
PMA NumberP150001
Supplement NumberS021
Date Received08/02/2017
Decision Date02/13/2018
Product Code OZO 
Docket Number 18M-0737
Notice Date 03/14/2018
Advisory Committee Clinical Chemistry
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding the upper arm as an alternate insertion site for the Guardian Sensor (3).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling