• 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...


             

Enhanced Surveillance


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P100003 / PAS002
Date Current Protocol Accepted 05/08/2014
Study Name Enhanced Surveillance
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description Objectives-To assess safety profile of the secure-C disc under general condition of use. Design- ESS
Study Population Description All patients who have received secure-C
Sample Size N/A
Data Collection Anticipated and un-anticipated adverse events including, but

not limited to major vessel injury, neurological damage, or nerve injury, device migration, removal, revision, and heterotopic codification.

Follow-up Visits and Length of Follow-up 10 years

Assessments: Annual for surgeon surveys, ongoing for the complains, explants and MDRs



Enhanced Surveillance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/29/2013 03/28/2013 On Time
one year report 09/28/2013 09/27/2013 On Time
18 month report 03/29/2014 03/28/2014 On Time
two year report 09/28/2014 09/26/2014 On Time
three year report 09/28/2015 09/30/2015 Overdue/Received
four year report 09/27/2016 09/28/2016 Overdue/Received
five year report 09/27/2017 09/28/2017 Overdue/Received
six year report 09/27/2018 09/27/2018 On Time
seven year report 09/27/2019 09/26/2019 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

-
-