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Device | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER |
Generic Name | INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY |
Applicant | ANIMAS CORP. 200 LAWRENCE DR. WEST CHESTER, PA 19380 |
PMA Number | P990026 |
Date Received | 06/01/1999 |
Decision Date | 03/22/2001 |
Withdrawal Date
|
04/23/2010 |
Product Code |
NCT |
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 |