• 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...


           

Enlighten PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Ongoing
Application Number /
Requirement Number
P220012 / PAS001
Date Original Protocol Accepted 10/20/2023
Date Current Protocol Accepted 04/24/2024
Study Name Enlighten PAS
Device Name Aurora EV-ICD System
Clinical Trial Number(s) NCT04060680 
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Interim or Final Data Summary
Interim Results Safety Results
Out of 228 subjects, 221 had successful implants of the Aurora EV-ICD device system. Adverse events were reported in 25 of the 221 patients. Eight were major complications, none were unanticipated, and 17 were procedurally related. There was one device deficiency, four study deviations, six system modifications, nine subject exits, including three subject deaths.
93 of the 221 patients had a lead repositioning, 40 due to atrial oversensing, and 31 due to suboptimal R wave sensing. Thirty-six (36) required re-tunneling. All re-tunneling occurred during initial implant.
Actual Number of Patients Enrolled 228
Actual Number of Sites Enrolled 111
Patient Follow-up Rate At the time of the visit cutoff date of 14-JUN-2024, 41 follow-up visits were reported.
Final Effect Findings N/A


Enlighten PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/19/2024 04/17/2024 On Time
1 year report 10/19/2024 10/17/2024 On Time
18 month report 04/19/2025    
2 year report 10/19/2025    
3 year report 10/19/2026    
4 year report 10/19/2027    


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

-
-