• 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...


Newly Enrolled Champion

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Progress Adequate
Application Number P100045 / PAS001
Date Current Protocol Accepted 02/14/2017
Study Name Newly Enrolled Champion
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

Newly Enrolled Champion Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 11/26/2014 02/09/2015 Overdue/Received
one year report 05/28/2015 06/04/2015 Overdue/Received
18 month report 11/26/2015 12/02/2015 Overdue/Received
two year report 06/26/2016 06/17/2016 On Time
three year report 06/26/2017 06/23/2017 On Time
four year report 06/26/2018 06/25/2018 On Time
five year report 06/26/2019 06/24/2019 On Time
final report 06/26/2020 04/24/2020 On Time

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