PMA P990026S008

Device: GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER
Applicant: Animas Corp.
PMA number: P990026
Supplement: S008
Product code: CGA
Decision date: 2002-08-26
Classification: Clinical Chemistry
Generic name: GLUCOSE OXIDASE, GLUCOSE
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.

Current openFDA PMA Record#

Device: GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER
Applicant: Animas Corp.
PMA number: P990026
Supplement: S008
Product code: CGA
Generic name: GLUCOSE OXIDASE, GLUCOSE
Decision date: 2002-08-26
Decision code: APPR
Date received: 2001-09-19
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.