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U.S. Department of Health and Human Services

Recognized Consensus Standards

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

Part B: Supplementary Information

Recognition Number 3-89: ISO 27186 First edition 2010-03-15, active implantable medical devices - four-pole connector system for implantable cardiac rhythm management devices - dimensional and test requirements. (Cardiovascular)

Date of Standard: 2010. 
Address of Standards Development Organization:
 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 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
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 Contact:
 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
* 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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