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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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.

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Long-Term F/u of EU patients PAS

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Study Status Progress Adequate
Application Number P150030 / PAS001
Date Current Protocol Accepted 08/21/2020
Study Name 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.

Long-Term F/u of EU patients PAS Schedule

Report Schedule
Date Due
FDA Receipt
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 04/16/2018 On Time
two year report 10/17/2018 10/15/2018 On Time
three year report 10/17/2019 10/10/2019 On Time
four year report 10/16/2020 10/15/2020 On Time
5 year report 10/16/2021 10/12/2021 On Time
final report 10/17/2022    

Contact Us

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

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