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FDA manuals

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FDA Advancing Health Medical Devices Instruction Manual

FDA Advancing Health Medical Devices Instruction Manual

September 3, 2023
EXECUTIVE SUMMARY FOR THE PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING Advancing Health Equity in Medical Devices Disclaimer: This Executive Summary is for discussion purposes only and does not represent draft or…
FDA Optilume BPH Catheter System Instruction Manual

FDA Optilume BPH Catheter System Instruction Manual

August 12, 2023
FDA Optilume BPH Catheter System Product Information The Optilume BPH Catheter System is a medical device designed for the treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH)…
FDA SurVeil Drug-Coated Balloon User Guide

FDA SurVeil Drug-Coated Balloon User Guide

August 12, 2023
FDA SurVeil Drug-Coated Balloon Product Information The SurVeilTM Drug-Coated Balloon is a medical device authorized by Federal (U.S.) law for the treatment of peripheral artery disease (PAD). It is specifically…
FDA Title 21 Vacancy Announcement Instructions

FDA Title 21 Vacancy Announcement Instructions

August 5, 2023
FDA Title 21 Vacancy Announcement Introduction The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs,…
FDA Breast Implants Instructions

FDA Breast Implants Instructions

July 22, 2023
FDA Breast Implants Product Information: Breast Implants Breast implants are medical devices that are used for breast augmentation, reconstruction, or revision surgery. Before undergoing any breast implant surgery, it is crucial…