f Post-Approval Studies (PAS) Database
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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 Follow-up Study

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Study Status Completed
Application Number /
Requirement Number
P020016 / PAS001
Date Original Protocol Accepted 09/21/2005
Date Current Protocol Accepted 09/21/2005
Study Name Long-term Follow-up Study
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 Objectives This is a follow-up of the pre-market study patients.
Study Population Study Population: All patients remaining at approval of device. Indication: For reconstruction of the temporomandibularjoint.
Sample Size 150 patients, 8 sites
Key Study Endpoints The primary endpoints include quality of life, jaw pain, jaw function and, maximum interincisal opening, patient satisfaction and implant removal.
Follow-up Visits and Length of Follow-up Patients will be followed for 3-years post implant. The follow-up schedule was not noted.
Interim or Final Data Summary
Actual Number of Patients Enrolled 288
Actual Number of Sites Enrolled Not stated
Patient Follow-up Rate 91%
Final Safety Findings Of the enrolled patients, 98.4% of known patients retained the implant at three years. However, there are 32 patients lost to follow-up and 12 with no response. If all patients lost to follow-up or with no response were included as failures at 3 years, survival of device implant would remain over 90%, indicating reasonable assurance of safety.
Study Strengths & Weaknesses The strength of the study is that there is adequate follow-up. The weaknesses of the study is that there were no hypothesis or sample size calculations.
Recommendations for Labeling Changes There were no recomendations were made for labeling changes.

Long-term Follow-up Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Request extension for 1 year report 09/22/2006 09/22/2006 On Time
1 year report 12/20/2006 12/21/2006 Overdue/Received
2 year report 09/21/2007 09/25/2007 Overdue/Received
Final Report 10/31/2008 11/03/2008 Overdue/Received

Contact Us

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

Additional Resources