Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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3-157
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Standard | |
ANSI AAMI ISO 25539-1:2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
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Scope/Abstract25539-1 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
N/A |
System, Endovascular Graft, Aortic Aneurysm Treatment |
Class 3
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MIH
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N/A |
Coronary Covered Stent |
HDE
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NIV
|
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |