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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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OSB Lead-Cont F/U of the IDE inop pts cohort(B)

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Application Number P130009 / PAS001
Current Plan Approved 08/02/2016
Study Name OSB Lead-Cont F/U of the IDE inop pts cohort(B)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective: To study the long term (5 year) device safety and effectiveness in continued follow-up of cohort B and six nested registries.

Design: A continued follow-up of Cohort B and six nested registries in IDE pivotal study, a prospective randomized, multi-center trial with two population cohorts undergoing transcatheter heart valve replacement therapy with SAPIEN XT THV.

Subjects will be all pivotal and CAP Patients enrolled in Cohort B and six nested registries (NR1, NR4, NR5, NR6) and who are not suitable for aortic valve surgery (i.e. inoperable patients).

Study Population Description all pivotal and CAP Patients enrolled in Cohort B and four nested registries (NR1, NR4, NR5, NR6)
Sample Size Currently, a total of 1790 patients from pivotal trials (560 from Cohort B and 1230 from the six registries) and 775 continued access (CAP) patients from the six nested registries (as of June 2, 2014) are available for continued follow-up.
Data Collection Through TVT-Registry
Follow-up Visits and Length of Follow-up Subjects will be followed annually through 5 years. Patients have been consented for up to 5 years follow-up, thus no re-consent is needed.

OSB Lead-Cont F/U of the IDE inop pts cohort(B) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 09/12/2015 09/11/2015 On Time
two year report 09/12/2016 09/09/2016 On Time
three year report 09/12/2017    
four year report 09/12/2018    
five year report 09/12/2019    

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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