• 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...


             

Enrollment Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P100049 / PAS002
Date Current Protocol Accepted 01/29/2018
Study Name Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/20/2012 09/20/2012 On Time
one year report 03/22/2013 03/26/2013 Overdue/Received
18 month report 09/20/2013 09/20/2013 On Time
two year report 03/22/2014 03/18/2014 On Time
three year report 03/22/2015 03/17/2015 On Time
four year report 03/21/2016 03/18/2016 On Time
five year report 03/21/2017 03/21/2017 On Time
six year report 03/21/2018 03/20/2018 On Time
seven year report 03/21/2019    
eight year report 03/20/2020    
Final report 03/22/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

Related Links

-
-