PMA P990026S011

Device: GLUCOWATCH 2 BIOGRAPHER
Applicant: Animas Corp.
PMA number: P990026
Supplement: S011
Product code: CGA
Decision date: 2002-03-21
Classification: Clinical Chemistry
Generic name: GLUCOSE OXIDASE, GLUCOSE
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE ELECTRICAL HARDWARE AND SOFTWARE OF THE ORIGINAL GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLUCOWATCH2 BIOGRAPHER AND IS INDICATED FOR: THE GLUCOWATCH2 BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INTENDED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES. THIS DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTHCARE FACILITIES. THE DEVICE IS FOR PRESCRIPTION USE ONLY. THE GLUCOWATCH 2 BIOGRAPHER IS INTENDED FOR USE AS AN ADJUNCTIVE DEVICE TO SUPPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE GLUCOWATCH2 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 SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.

Current openFDA PMA Record#

Device: GLUCOWATCH 2 BIOGRAPHER
Applicant: Animas Corp.
PMA number: P990026
Supplement: S011
Product code: CGA
Generic name: GLUCOSE OXIDASE, GLUCOSE
Decision date: 2002-03-21
Decision code: APPR
Date received: 2001-12-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE ELECTRICAL HARDWARE AND SOFTWARE OF THE ORIGINAL GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLUCOWATCH2 BIOGRAPHER AND IS INDICATED FOR: THE GLUCOWATCH2 BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INTENDED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES. THIS DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTHCARE FACILITIES. THE DEVICE IS FOR PRESCRIPTION USE ONLY. THE GLUCOWATCH 2 BIOGRAPHER IS INTENDED FOR USE AS AN ADJUNCTIVE DEVICE TO SUPPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE GLUCOWATCH2 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 SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.