FDA Product Code LZG: Pump, Infusion, Insulin
Insulin pump therapy enables flexible, physiological insulin delivery. FDA product code LZG covers insulin infusion pumps used by people with diabetes.
These devices deliver continuous subcutaneous insulin infusion via a programmable pump connected to a small catheter, providing basal insulin delivery and enabling mealtime bolus doses. They more closely mimic physiological insulin secretion than multiple daily injections.
LZG devices are Class II medical devices, regulated under 21 CFR 880.5725 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Medtronic Minimed, Insulet Corporation and Tandem Diabetes Care, Inc..
84
Total
84
Cleared
133d
Avg days
1989
Since
84 devices
Cleared
Dec 15, 2011
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
Insulet Corporation
General Hospital
183d
Cleared
Nov 09, 2011
T:SLIM (TM) INSULIN DELIVERY SYSTEM
Tandem Diabetes Care, Inc.
General Hospital
194d
Cleared
Feb 23, 2011
V-GO INSULIN DELIVERY SYSTEM
Valeritas, Inc.
General Hospital
55d
Cleared
Feb 20, 2009
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
Abbott Diabetes Care, Inc.
General Hospital
109d
Cleared
Dec 17, 2008
SYMPHONY METER REMOTE
Lifescan, Inc.
General Hospital
100d
Cleared
Oct 28, 2008
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
Roche Diagnostics
General Hospital
50d
Cleared
Apr 25, 2008
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
Medtronic Minimed
General Hospital
148d
Cleared
Jan 11, 2008
AVIATOR INSULIN PUMP
Abbott Diabetes Care, Inc.
General Hospital
193d
Cleared
Nov 01, 2006
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
Smiths Medical MD, Inc.
General Hospital
84d
Cleared
Jan 31, 2006
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
Medtronic Minimed
General Hospital
78d
Cleared
Dec 23, 2005
INSULIN PUMP
Abbott Diabetes Care, Inc.
General Hospital
242d
Cleared
Sep 13, 2005
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
Roche Diagnostics Corp.
General Hospital
173d
Cleared
Aug 16, 2005
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
Biovalve Technologies, Inc.
General Hospital
120d
Cleared
May 09, 2005
AMIGO INSULIN PUMP
Nipro Diabetes Systems, Inc.
General Hospital
90d
Cleared
Mar 18, 2005
ACCU-CHEK SPIRIT
Disetronic Medical Systems AG
General Hospital
150d
Cleared
Jan 03, 2005
IXL-II DIABETES MANAGEMENT SYSTEM
Insulet Corporation
General Hospital
89d
Cleared
Dec 10, 2004
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
Animas Corp.
General Hospital
53d
Cleared
Dec 01, 2004
MODIFICATION TO D-TRONPLUS
Disetronic Medical Systems AG
General Hospital
30d
Cleared
Jul 19, 2004
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
Medtronic Minimed
General Hospital
62d
Cleared
Jul 19, 2004
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
Medtronic Minimed
General Hospital
62d
Cleared
May 27, 2004
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
Smiths Medical MD, Inc.
General Hospital
358d
Cleared
May 21, 2004
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
Medtronic Minimed
General Hospital
67d
Cleared
Oct 23, 2003
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
Medtronic Minimed
General Hospital
100d
Cleared
Feb 10, 2000
R1000 SERIES INSULIN PUMP
Animas Corp.
General Hospital
140d