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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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OSB Lead-Ceramax PAS

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Application Number P070026 / PAS001
Current Plan Approved 03/18/2015
Study Name OSB Lead-Ceramax PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is prospective. .
Study Population Description Males and females who are appropriate candidates for primary hip

replacement with non-inflammatory degenerative joint disease.

Sample Size A total of 250 Subjects will be enrolled in the investigation

100 subjects recruited from IDE to PAS

150 new PAS subjects

There will be 5 sites enrolling IDE patients and 10 sites enrolling newly enrolled patients.
Data Collection The main study endpoint is device revision. Secondary endpoints include Harris Hip Score and radiographic findings.
Follow-up Visits and Length of Follow-up Follow-up to 10 years.

OSB Lead-Ceramax PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/23/2011 06/23/2011 On Time
18 month report 07/22/2012 07/24/2012 Overdue/Received
two year report 12/22/2012 12/26/2012 Overdue/Received
three year report 12/22/2013 12/20/2013 On Time
four year report 12/22/2014 12/17/2014 On Time
five year report 12/22/2015 12/21/2015 On Time
six year report 12/21/2016    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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