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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 3-66
Standard
ASTM F2081-06 (Reapproved 2017)
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
Scope/Abstract
This guide covers the identification of and recommended measurement methods for those dimensional attributes of vascular stents that are deemed relevant to successful clinical performance. The delivery system packaged with and labeled specifically for use during the placement of the stent is also included within the scope of this guide.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
Unclassified Coronary Drug-Eluting Stent Class 3 NIQ
Unclassified Stent, Carotid Class 3 NIM
Unclassified Stent, Coronary Class 3 MAF
Unclassified Stent, Iliac Class 3 NIO
Unclassified Stent, Renal Class 3 NIN
Unclassified Stent, Superficial Femoral Artery Class 3 NIP
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.
FDA Technical Contact
 Jhumur Banik
  FDA/OMPT/CDRH/ODE/DCD/PIDB/
  240-402-5239
  Jhumur.Banik@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Cardiovascular
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