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 and Complaint Analysis


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General
Study Status Ongoing
Application Number /
Requirement Number		 P090029 S006/ PAS001
Date Original Protocol Accepted 12/15/2016
Date Current Protocol Accepted  
Study Name Device Failure and Complaint Analysis
Device Name PRESTIGE LP CERVICAL DISC
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives Surveillance study
Study Population Patients diagnosed with degenerative disc disease at one or two levels in the cervical spine from C3 to C7 and implanted with Prestige LP
Key Study Endpoints The main study end-point is assessment of device retrievals from collected
explants.
Additional Study endpoints are as follows:
Complaint and MDR review
Collection of surgeon notes/descriptions of revision surgery
Analysis and histology of any adjacent or periprosthetic tissue collected
Follow-up Visits and Length of Follow-up 10 years
Interim or Final Data Summary
Interim Results Wear patterns consistent across retrievals conducted
Actual Number of Sites Enrolled Explants collected from all investigational and commercial sites.
Study Strengths & Weaknesses Study is limited by voluntary participation. Relatively few tissue collected due to consent issues. Direct
analysis offers clear long term analysis of failed devices.


Device Failure and Complaint Analysis Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 07/24/2017 07/21/2017 On Time
two year report 07/24/2018 07/20/2018 On Time
three year report 07/24/2019 06/05/2019 On Time
four year report 07/24/2020 06/10/2020 On Time
five year report 07/24/2021 07/16/2021 On Time
6 year report 08/31/2022 09/01/2022 Overdue/Received
7 year report 08/31/2023 09/01/2023 Overdue/Received
8 year report 08/31/2024    


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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