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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 3-109: AAMI / ANSI / ISO 27186:2010, active implantable medical devices - four-pole connector system for implantable cardiac rhythm management devices - dimensional and test requirements. (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:
Implantable permanent cardiac pacemaker and defibrillator electrodes (leads) and associated implantable pulse generators, pacemakers, defibrillators, and cardiac resynchronization therapy devices.
Processes Affected:
The standard provides dimensional and test requirements which allow interchangeability between implantable leads, pulse generators and defibrillators from different manufacturers
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Class 3 NIK
Unclassified Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Class 3 OJX
Unclassified Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Class 3 NVN
Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
Unclassified Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
Unclassified Permanent Defibrillator Electrodes Class 3 NVY
Unclassified Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Class 3 NKE
Relevant Guidance:
Guidance for the submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions: November 1, 2000
FDA Technical Contacts:
 Mark Fellman
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1306
  Silver Spring MD 20993
  301/796-6357
  email: mark.fellman@fda.hhs.gov
 Mitchell J. Shein
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1316
  Silver Spring MD 20993
  301/796-6363
  email: mitchell.shein@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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