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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ConservePlus New Enrollment PAS


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General
Study Status Terminated
Application Number /
Requirement Number		 P030042 / PAS002
Date Original Protocol Accepted 11/03/2009
Date Current Protocol Accepted 06/21/2010
Study Name ConservePlus New Enrollment PAS
Device Name CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Single-arm,Multi-center cohort
Study Population Paitents who have unilateral joint disease
Sample Size 183 patients
Key Study Endpoints Patients will undergo clinical and radiographic evaluation pre-operatively and post operated at 0-60 days, 12 and 24 months.
Follow-up Visits and Length of Follow-up Patients will undergo clinical and radiographic evaluation pre-operatively and post operated at 0-60 days, 12 and 24 months.
Length of follow up: 10 years


ConservePlus New Enrollment PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/21/2010 12/20/2010 On Time
12 month report 06/21/2011 05/06/2011 On Time
18 month report 12/21/2011 12/21/2011 On Time


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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