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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 REAL-TIME TRANSMITTER (MMT-7703)
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS120
Date Received08/03/2012
Decision Date08/17/2012
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
TRANSFER OF THE SUB-ASSEMBLY MANUFACTURING PROCESSES OF THE MINILINK REAL-TIME TRANSMITTER (MMT-7703) FROM INTRICON CORPORATION IN ARDEN HILLS, MINNESOTA TO ANALTERNATE MANUFACTURING FACILITY AT INTRICON IN ADMIRAX, SINGAPORE. THE MINILINK REAL-TIME TRANSMITTER IS A COMPONENT OF THE DEVICES.
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