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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
ApplicantMEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP150001
Supplement NumberS091
Date Received06/29/2021
Decision Date07/07/2021
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  
Addition of a second production line for Next Generation Pump (NGP) motors at Medtronics current supplier. The NGP motors are components of the MiniMed 630G and MiniMed 670G Insulin Pumps.
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