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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.
 
DeviceSEN-SERTER
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS171
Date Received11/03/2014
Decision Date12/03/2014
Product Codes MDS OYC 
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  
CHANGE IN THE CURING TIME DURING THE MANUFACTURING PROCESS FOR THE SENSERTER, WHICH IS A COMPONENT OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVELSYSTEM, GUARDIAN REAL-TIME CGM SYSTEM, MINILINK REAL-TIME SYSTEM, AND IPRO2PROFESSIONAL CGM SYSTEM.
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