Subcutaneous Implantable Defibrillator (S-Icd) System

FDA premarket approval P110042 · Implantable cardioverter defibrillator (non-CRT)

PMA numberP110042

Approval

Applicant
Boston Scientific Corporation
Received
December 23, 2011
Decision date
September 28, 2012 (APPR)
Supplements
205, latest July 23, 2026
Product code
LWS – Implantable Cardioverter Defibrillator (Non-Crt)

Official FDA PMA record

Approval order statement

APPROVAL FOR THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THIS DEVICE IS INDICATED TO PROVIDE DEFIBRILLATION THERAPY FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS INPATIENTS WHO DO NOT HAVE SYMPTOMATIC BRADYCARDIA, INCESSANT VENTRICULAR TACHYCARDIA, OR SPONTANEOUS, FREQUENTLY RECURRING VENTRICULAR TACHYCARDIA THAT IS RELIABLY TERMINATED WITH ANTITACHYCARDIA PACING.