FDA-recognized standard · Cardiovascular

AAMI TIR41: 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

Yes. FDA recognizes AAMI TIR41:2011/(R)2025 as recognition 3-110, entered 2018-09-17.

Recognized editions of AAMI TIR41

FDA recognitions of AAMI TIR41, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
3-110 AAMI TIR41:2011/(R)2025 2018-09-17 Complete —

Regulations

FDA lists these classification regulations against AAMI TIR41: 21 CFR 870.3610.

Product codes that cite AAMI TIR41

9 FDA product codes cite AAMI TIR41, including DXY, LWO, LWP, LWS, LWW.

  • DXY
  • LWO
  • LWP
  • LWS
  • LWW
  • MRM
  • NIK
  • NKE
  • NVZ

Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.