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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Carpentier Edwards PAS

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Application Number P860057 S023/ PAS001
Current Plan Approved 04/07/2005
Study Name Carpentier Edwards PAS
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 Design Description 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 Description N/A
Sample Size N/A
Data Collection 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
Final Study Results
Interim Safety Information N/A, This is a bench testing study.

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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