• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • 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...


PAS Registry Study for ExAblate 4000

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Protocol Overdue
Application Number P150038 S006/ PAS001
Study Name PAS Registry Study for ExAblate 4000
General Study Protocol Parameters
Study Design Other Study Design
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21

PAS Registry Study for ExAblate 4000 Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/16/2019 07/25/2019 Overdue/Received
one year report 12/16/2019 12/13/2019 On Time
18 month report 06/15/2020   Overdue
two year report 12/15/2020    
three year report 12/15/2021    
four year report 12/15/2022    

Contact Us

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

Related Links