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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Mortality and Autopsy


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General
Study Status Completed
Application Number /
Requirement Number		 P960009 / PAS002
Date Original Protocol Accepted 04/16/2010
Date Current Protocol Accepted 04/16/2010
Study Name Mortality and Autopsy
Device Name MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Interim or Final Data Summary
Actual Number of Patients Enrolled N/A
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Final Safety Findings N/A This is a bench study.
Final Effect Findings N/A
Study Strengths & Weaknesses N/A
Recommendations for Labeling Changes N/A


Mortality and Autopsy Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Mortality and Autopsy Report-FINAL 07/30/2012 07/30/2012 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

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