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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Longterm Followup Study


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General
Application Number P020016 / PAS001
Current Plan Approved 09/21/2005
Study Name Longterm Followup 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 Design Description This is a follow-up of the pre-market study patients.
Study Population Description Study Population: All patients remaining at approval of device. Indication: For reconstruction of the temporomandibularjoint.
Sample Size 150 patients, 8 sites
Data Collection 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.
Final Study Results
Interim Safety Information Study completed, see final results
Number of Patients 288
Number of Sites Not stated
Follow-up Rate 91%
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.
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.
Label Changes There were no recomendations were made for labeling changes.


Longterm Followup Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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

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

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