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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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EMBLEM S-ICD Modified 3501 Electrode PAS


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General
Study Status Study Pending
Application Number /
Requirement Number		 P110042 S203/ PAS001
Date Original Protocol Accepted 07/07/2026
Date Current Protocol Accepted 07/07/2026
Study Name EMBLEM S-ICD Modified 3501 Electrode PAS
Device Name EMBLEM S-ICD Electrode (Lead)
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source Admin Database
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives The objective of this analysis is to verify the continued the safety and effectiveness of the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) Model 3501 Electrode.
Study Population Analyses using CMS real-world data will include patients from the entire US fee-for-service Medicare patients, typically >65 years old. All patients that have been successfully implanted with an EMBLEM 3501 electrode, aligned with existing CMS coverage criteria, will be included in analyses of CMS data.
Analyses using LATITUDE data will include patients from the entire US population of implanted EMBLEM S-ICD 3501 Electrode patients who are being followed on LATITUDE.
Sample Size Number of subjects: 1013 electrodes
Assumptions for sample size estimation:
¿ Expected performance = 95%
¿ Performance goal = 92.5%
¿ One-sided significance level = 2.5%
¿ Power = 90%
Number of sites: N/A
Sites location: N/A – CMS -US
Key Study Endpoints Safety Endpoints
Primary: % of electrodes free from electrode-related complication from 1 month through 5- years
Secondary:
Effectiveness Endpoints
Primary:
Secondary: % of system impedances within range (obtained from US LATITUDE)
Follow-up Visits and Length of Follow-up 5 year follow-up


EMBLEM S-ICD Modified 3501 Electrode PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/21/2026 08/18/2026 On Time
1 year report 02/20/2027    
2 year report 02/20/2028    
3 year report 02/19/2029    
4 year report 02/19/2030    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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