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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 SUBCUTANEOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS128
Date Received11/14/2012
Decision Date02/11/2013
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE PACKAGING OF A LOW DROPOUT (LDO)REGULATOR INTEGRATED CIRCUIT TO HALOGEN FREE AND A CHANGE OF THE SOLDER PLATING TO PURE TIN SOLDER PLATING FOR THE MINILINK REAL-TIME TRANSMITTER (MMT-7703), CGMS IPRO RECORDER (MMT- 7709), AND IPRO2 RECORDER (MMT-7741) COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, CGMS IPRO, AND IPRO2 PROFESSIONAL GLUCOSE MONITORING SYSTEMS.
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