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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceGURADIAN LINK TRANSMITTER
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150001
Supplement NumberS005
Date Received11/28/2016
Decision Date12/19/2016
Product Code OZO 
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
RecallsCDRH Recalls
Approval Order Statement  
Add a new mold and press during the supplier’s manufacture of the Glucose Sensing Transmitter/Recorder bottom cover component of various Medtronic glucose monitoring systems.
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