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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Enhanced Surveillance Study


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General
Study Status Redesigned/Replaced Study
Application Number /
Requirement Number		 P090029 / PAS002
Date Original Protocol Accepted 04/06/2015
Date Current Protocol Accepted 04/06/2015
Study Name Enhanced Surveillance Study
Device Name PRESTIGE LP CERVICAL DISC
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Study Objectives- to fully characterize adverse events and
complaints when the device is used in the intended use population in the United States and in the rest of the world. Medtronic will attempt to collect the following information for any adverse events and complaints, including those complaints which are not associated with any adverse clinical effect. Design-enhanced surveillance
Study Population All device users
Sample Size N/A
Key Study Endpoints All adverse event data including subsequent surgeries, heterotopic ossification, device malfunction, and other serious device-related complications. Information will be actively collected from annual surgeon surveys and on the company website. Information will also be collected passively through complaints, MDRs, and annual systematic literature reviews.
All of the surgeons who have been trained on the use of PRESTIGE® LP Cervical Disc Prosthesis in the U.S. will be surveyed annually and the number of surveys issued and received will be reported. If a survey response includes any information related to an adverse event, you will collect additional data as specifically outlined in the ESS protocol and report that data to FDA.
Follow-up Visits and Length of Follow-up The study duration is 10 years.


Enhanced Surveillance Study 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 07/27/2015 Overdue/Received
18 month report 01/22/2016 01/29/2016 Overdue/Received
two year report 07/23/2016 07/22/2016 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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