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

TIR 41:2011/(R)2017

Standard Organization: AAMI

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

Recognition NumberCardiovascular
Recognition Date2018-09-17
Recognition List050
Recognition Number3-110
Extent Complete standard
Standards Orgs AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
STG Cardiovascular
FDA Tech  Matthew Hazelett   FDA/OMPT/CDRH/ODE/DCD/IEDB/   240-402-9875   Matthew.Hazelett@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
Unclassified Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Class 3 NIK
Unclassified Defibrillator, Implantable, Dual-Chamber Class 3 MRM
Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
Unclassified Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
Unclassified Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Class 3 NKE
Unclassified Pulse Generator, Permanent, Implantable Class 3 NVZ
Unclassified Pulse-Generator, Single Chamber, Sensor Driven, Implantable Class 3 LWO
Unclassified Pulse-Generator, Single Chamber, Single Class 3 LWW
§870.3610 Implantable Pacemaker Pulse-Generator Class 3 DXY

FDA Guidance:

There is no relevant guidance developed at this time.


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