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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 031 FR Publication Date 08/05/2013 
FR Recognition Number 3-66
Standard
ASTM F2081-06 (Reapproved 2013)
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
Extent of Recognition
Complete standard
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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