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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.
 
DeviceCONTINUOUS GLUCOSE MONITORING SYSTEM
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS006
Date Received09/21/2000
Decision Date01/09/2001
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING SITE FOR THE MANUFACTURER OF THE EXTERNAL COMPONENTS OF THE DEVICE. THE NEW SITE IS MINIMED, INC., NORTHRIDGE, CALIFORNIA.
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