f Post-Approval Studies (PAS) Database
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

Carpentier Edwards PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Completed
Application Number /
Requirement Number		 P860057 S023/ PAS001
Date Original Protocol Accepted 04/07/2005
Date Current Protocol Accepted 04/07/2005
Study Name Carpentier Edwards PAS
Device Name CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a bench testing study. It is a real-time aging for the other two models namely, 3000TFX, 6900PTFX, 2700TFX and 2800TFX.
Study Population N/A
Sample Size N/A
Key Study Endpoints Data will collected from: 1) tissue relaxation studies of zero timeand accelerated aged tissues, 2) histological evaluation of real-time aged whole valves, 3) real-time aged whole valve hydrodynamic testing, and 4) real-time aged whole valve structural integrity testing
Follow-up Visits and Length of Follow-up N/A




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

-
-