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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-Device Failure Study


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General
Study Status Other
Application Number P030053 / PAS002
Date Current Protocol Accepted 11/17/2006
Study Name OSB Lead-Device Failure Study
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The device failure study involves two components. The first component involves the collection of implant/surgery information and clinical data at the time of explantation. The second component involves visual inspection and physical testing of the explanted devices.
Study Population Description All explanted devices are to be returned to Mentor and analyzed and tested
Sample Size All returned devices are analyzed.
Data Collection An analysis was performed on the following categories to identify specific trends correlating to device failures: device type, size, clinical variables, visual observations, in-vivo time, surgical approach, device placement, incision size, pocket irrigation usage. Explanted devices underwent the following physical testing to assess the physical characteristics of the explanted devices: tension set, joint strength, ultimate elongation, gel cohesion.
Follow-up Visits and Length of Follow-up There is no patient follow-up in this study


OSB Lead-Device Failure Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 year report 11/16/2008 11/14/2008 On Time
3 year report 11/16/2009 11/16/2009 On Time
4 year report 11/16/2010 11/09/2010 On Time
5 year report 11/16/2011 11/09/2011 On Time
6 year report 11/15/2012 11/15/2012 On Time
7 year report 11/15/2013 11/12/2013 On Time

* Sponsor is reporting failure study data in the regular PMA Annual Report.



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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