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 Animas Corp..
85
Total
85
Cleared
133d
Avg days
1989
Since
85 devices
Cleared
Mar 29, 2012
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
Medtronic Minimed
General Hospital
66d
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
May 10, 2011
PEARL DIABETES MANAGEMENT SYSTEM
M2 Group Holdings, Inc.
General Hospital
435d
Cleared
Feb 23, 2011
V-GO INSULIN DELIVERY SYSTEM
Valeritas, Inc.
General Hospital
55d
Cleared
Dec 01, 2010
V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
Valeritas, LLC
General Hospital
282d
Cleared
Jan 25, 2010
SOLO MICROPUMP INSULIN DELIVERY SYSTEM
Medingo , Ltd.
General Hospital
89d
Cleared
Jul 23, 2009
SOLO INSULIN PATCH PUMP
Medingo , Ltd.
General Hospital
171d
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
Jun 24, 2008
SYMPHONY GLUCOSE MANAGEMENT SYSTEM
Animas Corp.
General Hospital
110d
Cleared
Jun 06, 2008
NILIMEDIX ADI
Nilimedix , Ltd.
General Hospital
437d
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
Dec 14, 2007
AMIGO INSULIN PUMP
Nipro Diabetes Systems, Inc.
General Hospital
184d
Cleared
Mar 30, 2007
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
Animas Corp.
General Hospital
109d
Cleared
Feb 02, 2007
DANA DIABECARE IIS
Sooil Development Co., Ltd.
General Hospital
112d
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
Jun 15, 2006
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001
Disetronic Medical Systems AG
General Hospital
76d
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