|
|
|
Device Name
|
|
|
|
|
Company
|
|
|
|
|
Date
Approved |
|
|
Device or Consumer
Information/Instructions |
Freestyle Libre Flash Glucose Monitoring System
supplements available
|
Abbott Diabetes Care, Inc. |
Sep 27, 2017 |
P160030 Approval Order
Summary of Safety & Effectiveness
Labeling
|
MiniMed 670G System
supplements available
|
Medtronic Minimed, Inc. |
Sep 28, 2016 |
P160017 Approval Order
Summary of Safety & Effectiveness
Labeling
|
FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM
supplements available
|
Abbott Diabetes Care, Inc. |
Sep 23, 2016 |
P150021 Approval Order
Summary of Safety & Effectiveness
Labeling
|
MINIMED 630G SYSTEM WITH SMARTGUARD(TM)
supplements available
|
Medtronic Minimed |
Aug 10, 2016 |
P150001 Approval Order
Summary of Safety & Effectiveness
Labeling
|
IPRO2 CGM SYSTEM WITH ENLITE SENSOR
supplements available
|
Medtronic Minimed |
Jun 17, 2016 |
P150029 Approval Order
Summary of Safety & Effectiveness
Labeling
|
PARADIGM REAL-TIME REVEL SYSTEM
supplements available
|
Medtronic Minimed |
Dec 07, 2015 |
P150019 Approval Order
Summary of Safety & Effectiveness
Labeling
|
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
supplements available
|
Tandem Diabetes Care, Inc. |
Sep 08, 2015 |
P140015 Approval Order
Summary of Safety & Effectiveness
Labeling
|
ANIMAS VIBE SYSTEM
supplements available
|
Animas Corp. |
Nov 25, 2014 |
P130007 Approval Order
Summary of Safety & Effectiveness
Labeling
|
MINIMED 530G SYSTEM
supplements available
|
Medtronic, Inc. |
Sep 26, 2013 |
P120010 Approval Order
Summary of Safety & Effectiveness
Labeling
|
DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
supplements available
|
Dexcom, Inc. |
Oct 05, 2012 |
P120005 Approval Order
Summary of Safety & Effectiveness
Labeling
|
