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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Recognition 08/21/2017 
FR Recognition Number 3-149
Standard
ISO 25539-1 Second edition 2017-02
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
Scope/Abstract
ISO 25539-1:2017 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.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
Unclassified Coronary Covered Stent Class f NIV
Unclassified System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Dorothy Abel
  FDA/OMPT/CDRH/ODE/DCD/VSDB/
  301-796-6366
  dorothy.abel@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
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