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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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ConservePlus Longer-Term PAS


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General
Application Number P030042 / PAS001
Current Plan Approved 07/16/2010
Study Name ConservePlus Longer-Term PAS
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 Design Description Multi-center, prospective, historically controlled
Study Population Description Patients who were previously enrolled in the CONSERVE Plus Total Resurfacing Hip System IDE
Sample Size 353 patients
Data Collection The primary endpoint is clinical success at 120 months post-operative for each patient.
Follow-up Visits and Length of Follow-up Patients will undergo clinical and radiographic evaluation post-operatively at years 5,8, & 10. Patients will also have serum levels of cobalt and chromium ions and renal function data collected postoperatively at years 5, 8, & 10.



Length of follow-up : Until each patient has reached 10 years, which will be in 2016.


ConservePlus Longer-Term PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/16/2011 01/12/2011 On Time
1 year report 05/04/2011 05/06/2011 Overdue/Received
18 month report 01/13/2012 01/13/2012 On Time
2 year report 05/16/2012 12/19/2012 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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