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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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Continued f/u of the premarket cohort

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Study Status Progress Adequate
Application Number P130021 S010/ PAS001
Study Name Continued f/u of the premarket cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of all living subjects who were enrolled under the IDE in Registry 6: TAV-in-SAV. The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.
Study Population Description All living subjects who were enrolled in the ¿TAV-in-SAV¿ Registry
Sample Size All living subjects.
Data Collection The safety and effectiveness endpoints include all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), change in functional status and quality of life, conduction disturbance requiring permanent pacemaker implantation, echocardiographic assessment, and valve dysfunction.
Follow-up Visits and Length of Follow-up 5 years

All subjects are followed at 30 days, 6 months, 12 months, and annually thereafter through 5 years post procedure.

Continued f/u of the premarket cohort Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 03/29/2016 11/27/2015 On Time
two year report 01/17/2017 01/18/2017 Overdue/Received
three year report 01/17/2018 01/18/2018 Overdue/Received
four year report 01/17/2019 01/17/2019 On Time
five year report 01/17/2020 01/16/2020 On Time
final report 04/30/2021 04/28/2021 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

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