PMA P110042

Device: EMBLEM S-ICD Electrode (Lead)
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S177
Product code: LWS
Decision date: 2026-02-20
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: multiple design changes to the EMBLEM S-ICD Electrode including improvement in fatigue endurance, and changes in insulation material and supplier, and updates to various subcomponents.

Current openFDA PMA Record#

Device: EMBLEM S-ICD Electrode (Lead)
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S203
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-02-20
Decision code: APPR
Date received: 2025-06-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: multiple design changes to the EMBLEM S-ICD Electrode including improvement in fatigue endurance, and changes in insulation material and supplier, and updates to various subcomponents.