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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 (CGMS)
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS022
Date Received12/12/2007
Decision Date01/11/2008
Product Code MDS 
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  
CHANGES IN THE MANUFACTURING PROCESS INCLUDING REPLACEMENT OF CENTRIFUGATION OF GLUCOSE OXIDASE WITH FILTRATION, AND INCORPORATION OF KEYPAD OVERLAY WITH A NEW ADHESIVE.
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