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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 PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS180
Date Received03/18/2015
Decision Date04/16/2015
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  
TRANSFER OF PURCHASING, RECEIVING, AND INCOMING INSPECTION ACTIVITIES OFCERTAIN EXTERNAL INSULIN PUMP COMPONENTS USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIMEPUMP SERIES AND THE MINIMED 530G SERIES FROM THE MEDTRONIC MINIMED NORTHRIDGE FACILITY TO THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY AND FEDEX/3PL FACILITIES IN PUERTO RICO. THE PARADIGM REAL�]TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, RESPECTIVELY.
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