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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-Fatigue & Stability Testing


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General
Application Number P060008 / PAS004
Current Plan Approved 10/10/2008
Study Name OSB Lead-Fatigue & Stability Testing
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This ia bench test study that performs pulsatile fatigue testing in a curved configuration and fatigue/durability particulates testing.
Study Population Description N/A
Sample Size N/A
Data Collection This ia bench test study that performs pulsatile fatigue testing in a curved configuration and fatigue/durability particulates testing.
Follow-up Visits and Length of Follow-up N/A
Final Study Results
Interim Safety Information N/A, This is a bench testing study.


OSB Lead-Fatigue & Stability Testing Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
stability report 10/17/2013 10/17/2013 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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