Premarket assessment of devices for treatment of critical limb ischemia: The role of Objective Performance Criteria and Goals
Author:
Publisher
Elsevier BV
Subject
Cardiology and Cardiovascular Medicine,Surgery
Reference3 articles.
1. FDA perspective on clinical trial design for cardiovascular devices;Chen;Ann Thorac Surg,2006
2. Prosthetic heart valves: Objective Performance Criteria versus randomized clinical trial;Grunkemeier;Ann Thorac Surg,2006
3. FDA perspective on clinical trial design for femoropopliteal stent correction of peripheral vascular insufficiency cardiovascular devices;Goode;Catheter Cardiovasc Interv,2007
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2. Objective Performance Goals Based on a Systematic Review and Meta-Analysis of Clinical Outcomes for Bare-Metal Stents and Percutaneous Transluminal Angioplasty for Hemodialysis-Related Central Venous Obstruction;Journal of Vascular and Interventional Radiology;2023-10
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