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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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Enhanced Surveillance Registry Study


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General
Study Status Completed
Application Number P110039 / PAS002
Date Current Protocol Accepted 03/15/2013
Study Name Enhanced Surveillance Registry Study
General Study Protocol Parameters
Study Design Active 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 17
Actual Number of Sites Enrolled 7 sites were enrolled; 4 sites enrolled patients
Patient Follow-up Rate N/A
Final Safety Findings There were two adverse events reported that were possibly or probably relatedto the device: post procedural pain (moderate severity, not serious), and erythema (mild, not serious).
Final Effect Findings This study did not have a primary effectiveness endpoint.
Study Strengths & Weaknesses This enhanced surveillance requirement was designed to collect data for two years of commercial experience, in order to characterize adverse events from a real world setting. There was no pre-specified sample size, and only 17 patients were enrolled out of 47 patients who received commercial treatments at the participating study sites.

Recommendations for Labeling Changes Due to the low sample size and study limitations, no labeling change is recommended.


Enhanced Surveillance Registry Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/18/2013 06/18/2013 Overdue/Received
one year report 10/18/2013 10/28/2013 Overdue/Received
18 month report 04/18/2014 05/07/2014 Overdue/Received
two year report 10/18/2014 10/29/2014 Overdue/Received
three year report 10/18/2015 11/06/2015 Overdue/Received
four year report 10/18/2016 11/02/2016 Overdue/Received
final report 03/12/2017 04/06/2017 Overdue/Received


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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