• 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...


             

ODE Lead-Long-Term F/u of EU patients PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Inadequate
Application Number P150030 / PAS001
Study Name ODE Lead-Long-Term F/u of EU patients PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multicenter, observational study that is currently in the follow-up data collection phase. Five of the seven study sites that contributed data to the PMA cohort will participate in this PAS.
Study Population Description All subjects in the investigational group of the PMA Cohort excluding one patient who died and one patient who was revised.
Sample Size A total of 135 subjects will be followed.
Data Collection The primary endpoint is implant survivorship at 10 years post study procedure.

Secondary endpoints include the following:

Patient outcomes as measured using the modified Harris Hip Score;

Radiographic evaluation to assess radiographic success defined as:

No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones; and

No femoral or acetabular subsidence greater than or equal to 5mm from baseline; and

No acetabular cup inclination changes greater than 4 degrees (4°)
Follow-up Visits and Length of Follow-up Patients will be followed for 10 years.


ODE Lead-Long-Term F/u of EU patients PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/17/2017 04/14/2017 On Time
one year report 10/17/2017 10/13/2017 On Time
18 month report 04/17/2018    
two year report 10/17/2018    
three year report 10/17/2019    
four year report 10/16/2020    
five year report 10/16/2021    


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

-
-