f Post-Approval Studies (PAS) Database
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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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PAS-Post-Market Surveillance Study/LongTerm Safety


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General
Study Status Delayed
Application Number /
Requirement Number		 P170013 / PAS001
Date Original Protocol Accepted 11/17/2020
Date Current Protocol Accepted 12/09/2022
Study Name PAS-Post-Market Surveillance Study/LongTerm Safety
Device Name Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives A multi-center, real-world evidence (RWE), single arm, retrospective and prospective study
Study Population The study population is comprised of patients who received the LVIS and LVIS Jr. for the treatment of intracranial aneurysms.
Sample Size No. of subjects: 250
The sample size was not statistically justified.
No. of sites: 13
Sites location: US
Key Study Endpoints Safety Endpoints: Neurological death, stroke, transient ischemic attack, in-stent stenosis, cerebral vasospasm

Effectiveness Endpoints: Aneurysm occlusion
Follow-up Visits and Length of Follow-up 5 years


PAS-Post-Market Surveillance Study/LongTerm Safety Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/28/2018 11/29/2018 Overdue/Received
one year report 05/30/2019 05/29/2019 On Time
18 month report 11/28/2019 11/27/2019 On Time
two year report 06/30/2020 05/22/2020 On Time
three year report 05/29/2021 05/27/2021 On Time
4 year report 05/30/2022 05/24/2022 On Time
5 year report 05/31/2023 05/31/2023 On Time
6 year report 05/30/2024    


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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