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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 NumberS151
Date Received01/28/2014
Decision Date02/27/2014
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
Approval Order Statement  
CHANGE IN THE INSULIN PUMP CASE ASSEMBLY MANUFACTURING PROCESS AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC) TO RECEIVE PUMP CASES DIRECTLY FROM A SUPPLIER WITH A NEW KEYPAD AND OVERLAY. THE INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM.
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