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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.
 
DeviceMINILINK TRANSMITTER (MMT-7703) AND CGMS IPRO RECORDER (MMT-7709)
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS115
Date Received03/08/2012
Decision Date04/26/2012
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE FROM A SINGLE CAVITY INJECTION MOLD TO A TWO CAVITYINJECTION MOLD FOR THE MANUFACTURE OF THE CONNECTOR HOUSING AND CONTACT COMPONENTS OF THE MINILINK TRANSMITTER (MMT-7703) AND IPRO DIGITAL RECORDER (MMT-7709). THE MINILINK TRANSMITTER AND IPRO DIGITAL RECORDER ARE COMPONENTS OF PARADIGM REAL-TIME, GUARDIANREAL-TIME AND IPRO CONTINUOUS GLUCOSE MONITORING SYSTEMS.
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