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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Ceramic Transcend Hip


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General
Study Status Completed
Application Number /
Requirement Number		 P030027 / PAS001
Date Original Protocol Accepted 01/07/2003
Date Current Protocol Accepted 01/07/2003
Study Name Ceramic Transcend Hip
Device Name CERAMIC TRANSCEND HIP ARTICULATION
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Interim or Final Data Summary
Interim Results Final Study Report received and under FDA review [Aug 6, 2010]
Actual Number of Patients Enrolled 1778
Actual Number of Sites Enrolled 12
Patient Follow-up Rate 49,3% in PMA cohort
Final Safety Findings 94.1% device survival at 5 years
Final Effect Findings 94.1% device survival at 5 years
Study Strengths & Weaknesses Poor follow-up rate, lack of Harris Hip Score
Recommendations for Labeling Changes TBD


Ceramic Transcend Hip Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final Report Amendment 01/29/2008 01/29/2008 On Time
Final Report 12/18/2009 02/03/2010 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

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