• 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...


           

PAS2 - WEB-IT Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P170032 / PAS002
Date Current Protocol Accepted  
Study Name PAS2 - WEB-IT Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
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 A prospective, single-arm, multicenter, international interventional cohort.
Study Population Description The study population is comprised of subjects with intracranial wide-neck aneurysms located at arterial bifurcations.
Sample Size The sample size is 200 patients.
Data Collection Study endpoints include adequate aneurysm occlusion, death, major stroke and additional neurological deficit.
Follow-up Visits and Length of Follow-up 5 years


PAS2 - WEB-IT Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/01/2019 06/27/2019 On Time
one year report 12/31/2019 12/26/2019 On Time
18 month report 06/30/2020 06/30/2020 On Time
two year report 12/30/2020 12/17/2020 On Time
three year report 12/30/2021    
four year report 12/30/2022    
five year report 12/30/2023    


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

-
-