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510(k) Summary of Safety and Effectiveness
510(k) Summary of Safety and Effectiveness

August 31, 2020 Medtronic Minimed, Inc. Nicole Birch Senior Regulatory  Affairs Specialist 18000 Devonshire Street Northridge, CA
August 31, 2020 Medtronic Minimed, Inc. Nicole Birch Senior Regulatory Affairs Specialist 18000 Devonshire Street Northridge, CA

Premarket Notification [510(k)]
Premarket Notification [510(k)]

Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report |  SpringerLink
Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report | SpringerLink

SSED Template
SSED Template

Management of diabetes and hyperglycaemia in the hospital - The Lancet  Diabetes & Endocrinology
Management of diabetes and hyperglycaemia in the hospital - The Lancet Diabetes & Endocrinology

Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical  Practice
Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical Practice

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

Continuous Glucose Monitors and Automated Insulin Dosing Systems in the  Hospital Consensus Guideline
Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline

Summary of Safety and Effectivness (SSED)Template
Summary of Safety and Effectivness (SSED)Template

An FDA Viewpoint on Unique Considerations for Medical-Device Clinical  Trials | NEJM
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM

Frontiers | Advancing Regulatory Science With Computational Modeling for  Medical Devices at the FDA's Office of Science and Engineering Laboratories
Frontiers | Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories

Continuous Glucose Monitoring Overview: Features and Evidence
Continuous Glucose Monitoring Overview: Features and Evidence

Continuous Glucose Monitor (CGM)
Continuous Glucose Monitor (CGM)

A Hybrid Closed-Loop Insulin Delivery System for the Treatment of Type 1  Diabetes - CADTH Issues in Emerging Health Technologies - NCBI Bookshelf
A Hybrid Closed-Loop Insulin Delivery System for the Treatment of Type 1 Diabetes - CADTH Issues in Emerging Health Technologies - NCBI Bookshelf

Flash Glucose Monitoring: A Patient's and Clinician's Caveats and Concerns  - Endocrine Practice
Flash Glucose Monitoring: A Patient's and Clinician's Caveats and Concerns - Endocrine Practice

CP.PHAR.534 Insulin Delivery Systems (V-Go, Omnipod, InPen)
CP.PHAR.534 Insulin Delivery Systems (V-Go, Omnipod, InPen)

Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology,  Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf
Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology, Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf

Guardian™ Sensor 3 for the MiniMed™ 670G/630G system (5/box) | Diabetes Shop
Guardian™ Sensor 3 for the MiniMed™ 670G/630G system (5/box) | Diabetes Shop

0070 Diabetes Tests- Programs and Supplies (1)
0070 Diabetes Tests- Programs and Supplies (1)

Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment  of Femoropopliteal Lesions | Circulation: Cardiovascular Interventions
Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions | Circulation: Cardiovascular Interventions

MiniMed 770G System - P160017/S076 | FDA
MiniMed 770G System - P160017/S076 | FDA

1.01.30 Artificial Pancreas Device Systems
1.01.30 Artificial Pancreas Device Systems

Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report |  SpringerLink
Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report | SpringerLink

Systematic analysis of the test design and performance of AI/ML-based  medical devices approved for triage/detection/diagnosis in the USA and  Japan | Scientific Reports
Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan | Scientific Reports

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

Department of Origin: Integrated Healthcare Services Effective Date:  09/15/22 Approved by: Medical Policy Quality Management Sub
Department of Origin: Integrated Healthcare Services Effective Date: 09/15/22 Approved by: Medical Policy Quality Management Sub