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 30, 1999
DISETRONIC D-TRON INSULIN INFUSION PUMP
Disetronic Medical Systems
General Hospital
20d
Cleared
Nov 15, 1999
MINIMED COM-STATION, HARDWARE-7301
Medtronic Minimed
General Hospital
68d
Cleared
Jun 15, 1999
DAHEDI INSULIN INFUSION PUMP
Disetronic Medical Systems
General Hospital
55d
Cleared
Jun 08, 1999
MINIMED 508 INSULIN PUMP
Medtronic Minimed
General Hospital
90d
Cleared
Sep 15, 1997
DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
Disetronic Medical Systems
General Hospital
31d
Cleared
Aug 15, 1997
MINIMED INFUSION PUMP, MODEL 507C
Medtronic Minimed
General Hospital
71d
Cleared
Apr 08, 1997
MINIMED INSULIN PUMP, MODEL 505
Medtronic Minimed
General Hospital
188d
Cleared
Apr 30, 1996
MINIMED INFUSION PUMP, MODEL MMT-507
Medtronic Minimed
General Hospital
119d
Cleared
Apr 12, 1991
H-TRON V 100 INSULIN INFUSION PUMP
Disetronic Medical Systems
General Hospital
114d
Cleared
Jul 02, 1990
MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP
Medtronic Minimed
General Hospital
88d
Cleared
Feb 23, 1990
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
Cardiac Pacemakers, Inc.
General Hospital
36d