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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 3-66: ASTM F 2081-06 (Reapproved 2013), standard guide for characterization and presentation of the dimensional attributes of vascular stents. (Cardiovascular)

Date of Standard: 2006. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
All stents indicated for vascular placement
Processes Affected:
PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
 Vertical, Device Guide, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
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 Guidance:
Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, April 18, 2010
FDA Technical Contacts:
 Maureen L. Dreher
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2110
  Silver Spring MD 20993
  301/796-2505
  email: maureen.dreher@fda.hhs.gov
 Tina Morrison
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1272
  Silver Spring MD 20993
  301/796-6310
  email: tina.morrison@fda.hhs.gov
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