GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER

FDA premarket approval P990026/S008 · decided 2002-08-26

Approval details

PMA number: P990026
Supplement: S008
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Trade name: GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER
Generic name: GLUCOSE OXIDASE, GLUCOSE
Applicant: Animas Corp.
Date received: 2001-09-19
Decision date: 2002-08-26
Days to decision: 341 days
Decision code: APPR
Product code: CGA
Advisory committee: Clinical Chemistry
Expedited review: Yes
Location: West Chester, PA
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 H

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Record	Firm	Date
SYMPHONY GLUCOSE MANAGEMENT SYSTEM (K080639)	Animas Corp.	2008-06-24
EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE (K080587)	Animas Corp.	2008-05-15
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE (K063674)	Animas Corp.	2007-03-30
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP (K042873)	Animas Corp.	2004-12-10
MODEL IR 1200 INSULIN PUMP (K032257)	Animas Corp.	2003-10-16
EZMANAGER PLUS (K022394)	Animas Corp.	2003-06-05
ANIMUS EZSERTER INFUSION SET INSERTER (K021700)	Animas Corp.	2002-06-04
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO (K021439)	Animas Corp.	2002-05-29