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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 3-110
Standard
AAMI  TIR 41:2011/(R)2017
Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
Scope/Abstract
This Technical Information Report provides guidance for the color coding and marking of IS-1, DF-1, IS4, and DF4connectors to reduce the potential for lead-to-pulse generator connection errors during implant surgery.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.3610 Implantable Pacemaker Pulse-Generator Class 3 DXY
N/A Pulse-Generator, Single Chamber, Sensor Driven, Implantable Class 3 LWO
N/A Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
N/A Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
N/A Pulse-Generator, Single Chamber, Single Class 3 LWW
N/A Defibrillator, Implantable, Dual-Chamber Class 3 MRM
N/A Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Class 3 NIK
N/A Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Class 3 NKE
N/A Pulse Generator, Permanent, Implantable Class 3 NVZ
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Matthew Hazelett
  FDA/OC/CDRH/OPEQ/CSPS/
  240-402-9875
  Matthew.Hazelett@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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