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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGLUCOWATCH G2 BIOGRAPHER
Classification Nameinstrument, glucose, noninvasive technology
Generic Nameinstrument, glucose, noninvasive technology\
ApplicantANIMAS CORP.
PMA NumberP990026
Supplement NumberS022
Date Received02/26/2004
Decision Date06/22/2004
Product Code
NCT[ Registered Establishments with NCT ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for multiple-patient use of the glucowatch g2 biographer.
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