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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.
 
DevicePARADIGM REAL-TIME INSULIN PUMP;PARADIGM REAL-TIME REVEL INSULIN PUMP
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS187
Date Received11/09/2015
Decision Date12/08/2015
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  
THE APPROVAL OF A MANUFACTURING CHANGE REGARDING THE PREPARATION OF THE PIEZO COMPONENT OF THE ELECTRONIC STACK ASSEMBLIES WITH THE PARADIGM REAL-TIME/REAL-TIME REVEL AND 530G SYSTEM PUMPS; A NEW PREPARATION FIXTURE IS BEING USED TO ASSEMBLE THE PIEZO COMPONENT. THE AFFECTED INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND MINIMED 530G SYSTEMS.
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