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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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SCENT Post-Approval Study


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General
Study Status Progress Adequate
Application Number P170024 / PAS001
Study Name SCENT Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of the trial is to determine the long-term safety and effectiveness of the Surpass Flow Diverter in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus.
Study Population Description Subjects with a large or giant intracranial aneurysm in the internal carotid artery up to the terminus
Sample Size 213 Subjects Enrolled
Data Collection The primary efficacy endpoint as determined by the angiographic core lab, is the percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (defined as = 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment at the target aneurysm at the 12 month follow-up visit. Safety success is achieved with a primary safety event rate significantly less than 20%
Follow-up Visits and Length of Follow-up 5 years


SCENT Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/11/2019 01/10/2019 On Time
one year report 07/13/2019 07/03/2019 On Time
18 month report 01/11/2020    
two year report 07/12/2020    
three year report 07/12/2021    


Contact Us

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

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