PMA P110042S210

Device: EMBLEM™ S-ICD Electrode (Lead) Model 3501
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S210
Product code: LWS
Decision date: 2026-07-07
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P110042/S203.

Current openFDA PMA Record#

Device: EMBLEM™ S-ICD Electrode (Lead) Model 3501
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S210
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-07-07
Decision code: APPR
Date received: 2026-03-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P110042/S203.