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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 AUTOMATIC GLUCOSE BIOGRAPHER
Generic NameGLUCOSE OXIDASE, GLUCOSE
Regulation Number862.1345
ApplicantANIMAS CORP.
200 LAWRENCE DR.
WEST CHESTER, PA 19380
PMA NumberP990026
Supplement NumberS008
Date Received09/19/2001
Decision Date08/26/2002
Withdrawal Date 04/23/2010
Product Code CGA 
Docket Number 02M-0412
Notice Date 09/16/2002
Advisory Committee Clinical Chemistry
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE GLUCOWATCH G2 BIOGRAPHER, WHICH EXPANDS THE INDICATIONS FOR USE TO INCLUDE CHILDREN/ADOLESCENTS (AGE 7 TO 17) TO THE CURRENTLY APPROVED INDICATIONS FOR USE. THIS DEVICE IS NOW INDICATED FOR THE FOLLOWING: 1) THE GLUCO WATCH G2 BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) AND CHILDREN/ADOLESCENTS (AGE 7 TO 17) WITH DIABETES. THIS DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES. THE DEVICE IS FOR PRESCRIPTION USE ONLY. 2) THE GLUCOWATCH G2 BIOGRAPHER IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO SUPPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. 3) THE BIOGRAPHER IS INDICATED FOR USE IN THE DETECTION AND ASSESSMENT OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZED THESE EXCURSIONS. INTERPRETATION OF BIOGRAPHER RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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