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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PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P870077 / PAS001
Date Original Protocol Accepted 09/25/1991
Date Current Protocol Accepted 09/25/1991
Study Name PAS
Device Name CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21


PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
PAS Annual Report through 8/21/07 09/25/2007 09/04/2007 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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