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Recognized Consensus Standards

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Recognition List Number: 026 FR Publication Date: 03/18/2011 

Part B: Supplementary Information

Recognition Number 3-58: AAMI / ANSI / ISO 5840:2005/(R)2010, cardiovascular implants - cardiac valve prostheses. (Cardiovascular)

Date of Standard: 2010. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Replacement Heart Valves
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical
Extent of Recognition:
Complete standard and any annexes, except for exclusions, differences, and additions in the relevant guidance.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Heart-Valve, Allograft Class 3 MIE
Unclassified Heart-Valve, Mechanical Class 3 LWQ
Unclassified Heart-Valve, Non-Allograft Tissue Class 3 LWR
Unclassified Pulmonic Valved Conduit Class f MWH
Unclassified Pulmonary Valve Prosthesis Percutaneously Delivered Class f NPV
§870.3925 Replacement Heart-Valve Class 3 DYE
Relevant Guidance:
Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications
FDA Technical Contact:
 Carolyn Vaughan
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1230
  Silver Spring MD 20993
  301/796-6338
  email: carolyn.vaughan@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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