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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 029 Date of Entry 08/20/2012 
FR Recognition Number 3-104
ASTM F2914-12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
Scope/Abstract
This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example drug-devices, biologic devices or drug biologics) may require additional considerations, depending on their nature.
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
Unclassified System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH
Unclassified Transcatheter Septal Occluder Class 3 MLV
Regulation Number Device Name Device Class Product Code
§870.3375 Filter, Intravascular, Cardiovascular Class 2 DTK
FDA Technical Contacts
 Heather Agler
  FDA/OC/CDRH/OSPTI/DAHRSSP/AHRRC/
  301-796-6340
  heather.agler@fda.hhs.gov
 Jhumur Banik
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-5239
  Jhumur.Banik@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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