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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Autopsy Study


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General
Application Number P100026 / PAS005
Current Plan Approved 02/14/2014
Study Name OSB Lead-Autopsy Study
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 Design Description This is a non-randomized, open-label, observational study of patients treated with the RNS System.
Study Population Description 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
Data Collection 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


OSB Lead-Autopsy Study Schedule

Report 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    
five year report 11/13/2018    


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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