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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New England Bapt Hospital Joint Registry


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General
Study Status Terminated
Application Number /
Requirement Number		 P040023 / PAS007
Date Original Protocol Accepted 05/03/2005
Date Current Protocol Accepted 06/12/2012
Study Name New England Bapt Hospital Joint Registry
Device Name DURALOC OPTION CERAMIC HIP SYSTEM
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Registry study
Study Population The study population is comprised of patients who receive the Duraloc Option hip in the post-market environment.
Sample Size The sample size is 225 patients.
Key Study Endpoints The primary endpoint is device revision.
Follow-up Visits and Length of Follow-up The length of follow-up is 5 years Follow-up visits will occur per standard medical practice.


New England Bapt Hospital Joint Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Report 07/03/2012 06/26/2012 On Time
3 year report 05/17/2013 05/30/2013 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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