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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New Enrollment of extreme risk patients


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General
Study Status Terminated
Application Number /
Requirement Number		 P130021 / PAS003
Date Original Protocol Accepted 01/17/2014
Date Current Protocol Accepted  
Study Name New Enrollment of extreme risk patients
Device Name MEDTRONIC COREVALVE SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21




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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