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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.
 
DeviceSOF SENSOR
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS162
Date Received10/17/2014
Decision Date11/21/2014
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  
CHANGES TO THE FABRICATION PROCESS FOR THE SOF-SENSOR (MMT-7002). THE SOF-SENSOR IS A COMPONENT OF THE CONTINUOUS GLUCOSE MONITORING SYSTEM, PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL TIME CGM SYSTEM, MINILINK REAL-TIME SYSTEM, IPRO RECORDER CGM SYSTEM, AND IPRO 2 PROFESSIONAL CGM SYSTEM.
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