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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.
 
DeviceMINILINK REAL-TIME SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS119
Date Received07/12/2012
Decision Date12/26/2013
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW WATERTIGHT TESTER ACCESSORY DEVICE AS WELL AS LABELINGCHANGES RELATED TO NEW CLEANING AND DISINFECTION PROTOCOLS FOR THE MINILINK TRANSMITTER AND NEW WATERTIGHT TESTER. THE MINILINK TRANSMITTER (MODEL MMT-7703) AND THE WATERTIGHT TESTER (MODEL MMT-7726) ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REALTIME SYSTEM, AND MINI LINK REAL-TIME SYSTEM.
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