f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Device Failure


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General
Study Status Redesigned/Replaced Study
Application Number /
Requirement Number		 P090029 / PAS003
Date Original Protocol Accepted 03/11/2016
Date Current Protocol Accepted 12/15/2016
Study Name Device Failure
Device Name PRESTIGE LP CERVICAL DISC
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives Objective: to assess long-term modes of device failure. the Design: the study incorporates explant analysis, histopathological analysis using periprosthetic tissues removed during explant surgery, and metal ion testing using blood samples analyzed for trace metal concentrations.
Study Population Retrievals from Extended Follow-up of Premarket Cohort, New Enrollment study and other sources (no comparator group)
Sample Size All explanted and retrieved device components which were returned to the company
Key Study Endpoints Effectiveness endpoints ? N/A; Safety endpoints: outcomes of explant analysis, histopathological analysis, and metal ion testing with regards to device failure modes
Follow-up Visits and Length of Follow-up N/A


Device Failure Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/22/2015 02/25/2015 Overdue/Received
one year report 07/24/2015 07/17/2015 On Time
18 month report 02/22/2016 01/27/2016 On Time
two year report 07/23/2016 07/20/2016 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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