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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Perimount Magna Pericardial Bioprosthesis


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General
Study Status Completed
Application Number /
Requirement Number		 P860057 S018/ PAS001
Date Original Protocol Accepted 11/14/2003
Date Current Protocol Accepted  
Study Name Perimount Magna Pericardial Bioprosthesis
Device Name CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC
General Study Protocol Parameters
Study Design Prospective Cohort Study
Analysis Type Descriptive


Perimount Magna Pericardial Bioprosthesis Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final Report for Fatigue Studies 11/13/2007 08/22/2007  


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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