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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-Novation PAS


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General
Study Status Progress Adequate
Application Number P050039 / PAS002
Date Current Protocol Accepted 04/03/2017
Study Name OSB Lead-Novation PAS
General Study Protocol Parameters
Study Design Active Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Multi-center active surveillance study. The primary objectives of the study is to examine long-term device performance device survival under actual conditions of use.
Study Population Description Patients who receive the Novation Ceramic Articulation Hip System in the post-market environment.

Sample Size The sample size is 375 hips.
Data Collection The main study endpoint is device survival. Secondary endpoints include adverse radiographic changes.

Follow-up Visits and Length of Follow-up The length of patient follow-up is 10 years.





OSB Lead-Novation PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
12 month report 08/03/2011 07/25/2011 On Time
yearly report 08/03/2012 07/02/2012 On Time
Yearly report-active surveillance 08/28/2012 08/28/2012 On Time
year report 08/03/2013 07/05/2013 On Time
12-Month Interim-Active Surveillance Status Report 08/30/2013 08/28/2013 On Time
yearly report 08/30/2014 07/03/2014 On Time
Active Surveillance Report 09/04/2014 09/04/2014 On Time
yearly report 08/27/2015 07/01/2015 On Time
Active Surveillance Report 09/04/2015 08/27/2015 On Time
Active Surv Report 03/04/2016 02/29/2016 On Time
yearly active surveillance report 08/27/2016 08/30/2016 Overdue/Received
active surveillance report 01/13/2017 01/13/2017 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
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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