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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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GORE CARDIOFORM New Enrollment PAS


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General
Study Status Progress Adequate
Application Number P050006 S060/ PAS002
Date Current Protocol Accepted 09/17/2019
Study Name GORE CARDIOFORM New Enrollment PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


GORE CARDIOFORM New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/28/2018 09/20/2018 On Time
one year report 03/30/2019 03/20/2019 On Time
18 month report 09/28/2019 09/23/2019 On Time
two year report 03/29/2020    
three year report 03/29/2021    
four year report 03/29/2022    
five year report 03/29/2023    


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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