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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, PARADIGN REAL TIME REVEL INSULIN PUMP
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS137
Date Received08/27/2013
Decision Date09/24/2013
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
RecallsCDRH Recalls
Approval Order Statement  
ADDITION OF AN ALTERNATE FACILITY WAREHOUSE SPACE FOR THE HANDLING OF RAW MATERIALS INCLUDING SUBASSEMBLIES AND COMPONENTS FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-522, MMT-522K, MMT-722, MMT-722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-523, MMT-523K, MMT-723, MMT-723K). THE PARADIGM REAL-TIME INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEM.
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