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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameinstrument, glucose, noninvasive technology
Generic Nameinstrument, glucose, noninvasive technology
200 lawrence dr.
west chester, PA 19380
PMA NumberP990026
Date Received06/01/1999
Decision Date03/22/2001
Withdrawal Date 04/23/2010
Product Code
Docket Number 01M-0371
Notice Date 08/29/2001
Advisory Committee Clinical Chemistry
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the glucowatch(r) automatic glucose biographer. The device is indicated for: the glucowatch(r) automatic glucose biographer is a glucose monitoring device indicated for detecting trends and tracking patterns in glucose levels in adults (age 18 and older) with diabetes. The device is intended for use by patients at home and in health care facilities. The glucowatch biographer is indicated for use as an adjunctive device to supplement, not replace, information obtained from standard home glucose monitoring devices. 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 minimize these excursions. Interpretation of biographer results whould be based on the trends and patterns seen with several sequential readings over time.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022