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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.
 
DeviceGLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR
Generic NameINSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
ApplicantANIMAS CORP.
200 LAWRENCE DR.
WEST CHESTER, PA 19380
PMA NumberP990026
Supplement NumberS018
Date Received07/01/2003
Decision Date11/20/2003
Withdrawal Date 04/23/2010
Product Code NCT 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE SIGNAL PROCESSING ROUTINE AND DATA POINT SCREENING PARAMETERS OF THE BIOGRAPHER TO REDUCE THE NUMBER OF SKIPPED READINGS, MODIFICATIONS TO THE DOWN ALERT OF THE BIOGRAPHER TO INCREASE THE SPECIFICITY OF THE ALARM FEATURE AND AN AUTOSENSOR FORMULATION CHANGE TO IMPROVE THE BIOGRAPHER CALIBRATION.
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