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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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Autopsy Study


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General
Study Status Completed
Application Number /
Requirement Number		 P100026 / PAS005
Date Original Protocol Accepted 11/14/2013
Date Current Protocol Accepted 02/14/2014
Study Name Autopsy Study
Device Name NEUROPACE RNS SYSTEM
General Study Protocol Parameters
Study Design Other Study Design
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 This is a non-randomized, open-label, observational study of patients treated with the RNS System.
Study Population All patients implanted with the RNS Neurostimulator and/or Lead(s) who die and in whom it is possible to obtain an autopsy, including patients in the LLT study and the RNS System PAS2 study, as well as non-study patients whose product data are tracked via the NeuroPace customer service and product monitoring systems.
Sample Size A minimum of 15 autopsies must be conducted as part of the study
Key Study Endpoints 1. Data from autopsies obtained from any patient implanted with the Neurostimulator and Lead(s).

2. Secondary endpoint - additional data. Demographic and other data for each patient whose autopsy data are included in the primary endpoint
Follow-up Visits and Length of Follow-up N/A and N/A
Interim or Final Data Summary
Actual Number of Patients Enrolled 19
Actual Number of Sites Enrolled NA
Patient Follow-up Rate NA
Final Safety Findings No safety concerns
Final Effect Findings No effectiveness concerns
Study Strengths & Weaknesses Descriptive data provided
Recommendations for Labeling Changes None


Autopsy Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/15/2014 05/09/2014 On Time
one year report 11/14/2014 11/07/2014 On Time
18 month report 05/15/2015 04/24/2015 On Time
two year report 11/14/2015 10/08/2015 On Time
three year report 11/13/2016 10/17/2016 On Time
four year report 11/13/2017 11/13/2017 On Time
five year report 11/30/2018 11/14/2018 On Time
six year report 11/14/2019 11/15/2019 Overdue/Received
seven year report 11/15/2020 11/03/2020 On Time
final report 12/15/2021 11/04/2021 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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