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

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Post-Approval Study

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Study Status Progress Adequate
Application Number P140016 / PAS001
Study Name Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective:

To monitor longer-term (5 year) safety and effectiveness of the device.

Design: Prospective, nonrandomized, single-arm, multicenter, multinational study. This is a continued follow-up of premarket cohorts, including pivotal study and continued access cohorts in accordance with the previously approved Investigational Device Exemption protocol.

Study Population Description Subjects who are enrolled in the aneurysm/ulcer clinical study initiated prior to device approval and alive at the time of the device approval.
Sample Size The total patients who are alive at the time of device approval
Data Collection Primary safety endpoints:

The 30 day freedom from major adverse event (MAE) rate

Primary effectiveness endpoints:

The 12-month device success rate.

Follow-up Visits and Length of Follow-up 5 years

post-procedure (pre-discharge), 30 days, 6 months, 12 months, yearly thereafter through 5 years.

Post-Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 09/14/2016 09/14/2016 On Time
two year report 09/14/2017 09/14/2017 On Time
three year report 09/14/2018 09/14/2018 On Time
four year report 09/14/2019 09/12/2019 On Time
five year report 09/13/2020    

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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