| 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 Number | Cardiovascular |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 3-110 |
| 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 |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| There is no relevant guidance developed at this time. |