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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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OSB Lead-Actual Conditions of Use Study


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General
Application Number P050050 / PAS002
Current Plan Approved 09/01/2016
Study Name OSB Lead-Actual Conditions of Use Study
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 Prospective, multi-center, single-arm study
Study Population Description Consecutive subjects meeting all inclusion criteria and none of the exclusion criteria and giving informed consent will be enrolled in the study.The subjects from the Continued Access Cohort of the IDE study will serve as the historical control in the PAS."

Sample Size 98
Data Collection Overall patient success is defined as: a. 40 point improvement in total Buechel-Pappas Scale score, b. No device failures, revisions, or removals, c. Radiographic success (no clinically significant radiographic evidence of loosening, tilting, or migration > 4mm) d. No major complications

Follow-up Visits and Length of Follow-up Patients in the Actual Conditions of Use study will be evaluated at baseline, 6 weeks, and 6, 12, and 24 months postoperatively"


OSB Lead-Actual Conditions of Use Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/29/2010 03/29/2010 On Time
1 year report 05/27/2010 05/28/2010 Overdue/Received
18 month report 11/25/2010 11/18/2010 On Time
2 year report 05/27/2011 05/27/2011 On Time
3 year report 05/26/2012 05/25/2012 On Time
4 year report 05/27/2013 05/28/2013 Overdue/Received
5 year report 06/26/2014 06/27/2014 Overdue/Received
6 year report 06/26/2015 06/26/2015 On Time
7 year report 06/26/2016 06/24/2016 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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