3/28/2024 0 Comments Kink compatibility checklistIf you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems Principal Safety and Effectiveness Table.Balloon Inflation and Deflation Time (Balloon Expandable Stents Only).Balloon Pressure Balloon Expandable Stents Only) Balloon Compliance (Stent Diameter vs.Balloon Fatigue (Repeat Balloon Inflations Balloon Expandable Stents Only).Balloon Rated Burst Pressure (Balloon Expandable Stents Only).Delivery System Dimensional and Functional Attributes.
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