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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 Pump
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP150001
Supplement NumberS025
Date Received10/06/2017
Decision Date10/26/2017
Product Code OZO 
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  
Second manufacturing site for a molded plastic component that supports and cushions the printed circuit board assembly within the 630G and 670G insulin pumps. The 630G and 670G insulin pumps are components of the MiniMed 630G and MiniMed 670G systems, respectively.
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