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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.
 
DeviceGUARDIAN RT
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS012
Date Received02/28/2005
Decision Date08/24/2005
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE SENSOR TO INCLUDE THE USE OF HUMAN SERUM ALBUMIN IN PLACE OF BOVINE SERUM ALBUMIN AS A STABILIZER AND A CHANGE TO THE MANUFACTURING PROCESS REMOVING THE OUTER HYDROPHILIC MEMBRANE.
Post-Approval StudyShow Report Schedule and Study Progress
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