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
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
Dec 19, 2003
IXL DIABETES MANAGEMENT SYSTEM
Insulet Corp.
General Hospital
233d
Cleared
Nov 18, 2003
PARADIGMPAL, MODEL MMT-7330
Minimed, Inc.
General Hospital
186d
Cleared
Oct 23, 2003
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
Medtronic Minimed
General Hospital
100d
Cleared
Oct 16, 2003
MODEL IR 1200 INSULIN PUMP
Animas Corp.
General Hospital
86d
Cleared
Jun 17, 2003
MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
Minimed, Inc.
General Hospital
118d
Cleared
Jun 05, 2003
EZMANAGER PLUS
Animas Corp.
General Hospital
317d
Cleared
Oct 29, 2002
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
Disetronic Medical Systems AG
General Hospital
14d
Cleared
Sep 11, 2002
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
Disetronic Medical Systems AG
General Hospital
16d
Cleared
Aug 13, 2002
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
Deltec, Inc.
General Hospital
165d
Cleared
Aug 02, 2002
DISETRONIC D-TRON INSULIN INFUSION PUMP
Disetronic Medical Systems AG
General Hospital
70d
Cleared
Aug 02, 2002
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
Sooil Development Co., Ltd.
General Hospital
16d
Cleared
Jun 24, 2002
GLUCOPRO EVO INFUSION PUMP
Nipro Diabetes Systems, Inc.
General Hospital
263d
Cleared
May 29, 2002
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
Animas Corp.
General Hospital
23d
Cleared
Dec 12, 2001
MICROJET QUARK, MODEL U100 OR U40
Cane S.R.L.
General Hospital
27d
Cleared
Aug 14, 2000
DANA DIABECARE
Sooil Development Co., Ltd.
General Hospital
82d