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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.
 
DeviceMEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS109
Date Received02/08/2012
Decision Date03/09/2012
Product Code MDS 
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  
IMPLEMENTATION OF A NEW CLEANING SYSTEM CALLED ISOPROPYL ALCOHOL RECIRCULATING CLEANING OR IPARC. THE IPARC SYSTEM IS USED TO CLEAN THE SENSOR BASE AND NEEDLE ASSEMBLY COMPONENTS OF THE SOF-SENSOR GLUCOSE SENSOR (MMT-7002, MMT-7003). THE SOF-SENSOR IS A COMPONENT OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME SYSTEM, CGMS IPRO SYSTEM AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM.
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