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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Stelkast Surpass Active PAS

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Study Status Terminated
Application Number P040051 / PAS002
Date Current Protocol Accepted 04/22/2011
Study Name OSB Lead-Stelkast Surpass Active PAS
General Study Protocol Parameters
Study Design Active Surveillance
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Active surveillance supplemented by prospective multi-center cohort study

Study Population Description Patients implanted with the Stelkast Surpass Acetabular System
Sample Size 320 patients active surveillance, 20 patients prospective multi-center cohort

Patient sites: sites for the active surveillance component and sites for the prospective multi-center study
Data Collection Study endpoints include device related adverse events, device revision, removal. reoperations, and supplemental fixation.

Follow-up Visits and Length of Follow-up Annual

Length of follow up: 10 Years

OSB Lead-Stelkast Surpass Active PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/22/2011 10/20/2011 On Time
one year report 04/22/2012 05/04/2012 Overdue/Received
18 month report 12/21/2012 12/21/2012 On Time
two year report 04/22/2013 04/23/2013 Overdue/Received
three year report 05/22/2014 05/22/2014 On Time
four year report 06/06/2015 05/07/2015 On Time

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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