f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail

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.

Learn more...


EMBLEM S-ICD Electrode Model 3501 PAS

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Progress Inadequate
Application Number /
Requirement Number
P110042 S077/ PAS001
Study Name EMBLEM S-ICD Electrode Model 3501 PAS
Device Name Model 3501 EMBLEM S-ICD subcutaneous Electrode
General Study Protocol Parameters
Study Design Other Study Design
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Primary analyses will use existing data sources from patients implanted with the EMBLEM S-ICD Electrode Model 3501 and represented in the following databases:
NCDR: ICD Registry;
LATITUDE NXT Patient Management System;
CMS Claims Database; and
National Death Index (linage to NCDR patients).
Each database is associated with a unique, independently-powered co-primary endpoint. Comparisons will be made to the predecessor EMBLEM S-ICD Electrode Model 3401. An unpowered secondary analysis will be performed using patients from Truven Marketscan Database (private insurance claims).
Study Population Patients will come from the US implant population with EMBLEM S-ICD Electrode Model 3501 whose data are captured in one of the databases utilized for this study.
Sample Size The primary analysis cohorts will consist of consecutive patients implanted with EMBLEM S-ICD Electrode Model 3501 identified in the following databases:
NCDR ICD Registry (N=2,100);
LATITUDE NXT Patient Management System (N=2,000);
CMS Claims Database (N=2,100); and
National Death Index linkage to NCDR patients (N=2,100).
The sample sizes given in the parentheses were calculated based on the provisional statistical assumptions given in Table 1-2 and will be updated based on PAS data for the EMBLEM S-ICD Electrode Model 3401. The sample sizes will be re-estimated and patients will be added if needed to ensure 90% power is maintained.
Key Study Endpoints Primary Endpoints:
NCDR: The first primary endpoint evaluates the rate of Model 3501 implant and periprocedural complications.
Remote Monitoring (LATITUDE NXT): The second primary endpoint evaluates the five-year rate of Model 3501 EMBLEM S-ICD Electrode integrity alerts.
Administrative Claims (CMS): The third primary endpoint evaluates the five-year rate of Model 3501 EMBLEM S-ICD Electrode complications requiring reoperation or hospitalization.
National Death Index: The fourth primary endpoint evaluates the five year rate of Model 3501 EMBLEM S-ICD Electrode patient deaths from any cause.
Secondary Endpoint:
Administrative Claims (Truven): The secondary endpoint evaluates the five-year rate of Model 3501 EMBLEM S-ICD Electrode complications requiring reoperation or hospitalization.
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Interim Results The study is on track to meet enrollment goals set at the 10-year mark. Occurrence of procedural complications, high impedance alerts and necessary explanation remain

Actual Number of Patients Enrolled 19,467
Actual Number of Sites Enrolled The study utilizes existing real-world data sources, and hence it does not require site enrollment.
Patient Follow-up Rate 97.3%
Study Strengths & Weaknesses At the time of this report there are no updates to the strengths and weaknesses of the study. The study is performing as expected and enrollment remains on-track. The Model 3510 S-ICD is performing as expected compared to the Model 3401 S-ICD Electrode predecessor.

EMBLEM S-ICD Electrode Model 3501 PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 03/30/2018 03/30/2018 On Time
one year report 09/29/2018 09/28/2018 On Time
18 month report 03/30/2019 03/29/2019 On Time
two year report 09/29/2019 09/30/2019 Overdue/Received
36 month report 03/30/2020 03/30/2020 On Time
three year report 09/28/2020 09/24/2020 On Time
interim report 12/07/2020 12/07/2020 On Time
4 year report 09/28/2021 09/27/2021 On Time
5 year report 09/28/2022 10/03/2022 Overdue/Received
6 year report 09/28/2023    

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