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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.
 
DeviceARTIFICIAL PANCREAS DEVICE SYSTEM
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS045
Date Received11/04/2014
Decision Date12/04/2014
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
IMPLEMENTATION OF FIVE ADDITIONAL PIECES OF EQUIPMENT AT A CONTRACT MANUFACTURER TO SUPPORT THE MANUFACTURE OF THE LITHIUM POLYMER BATTERIES FOR THE MINILINKREAL-TIME TRANSMITTER MODEL NUMBER MMT-7703 AND THE IPRO2 DIGITAL RECORDER MODEL NUMBER MMT-7741. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL�] TIME SYSTEM, PARADIGM REAL�] TIME REVEL SYSTEM, GUARDIAN REAL�]TIME SYSTEM, MINILINKREAL�]TIME SYSTEM, AS WELL AS THE MINIMED 530G SYSTEM. THE IPRO2 RECORDER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM.
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