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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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PATHWAY Clinical Trial PAS


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General
Study Status Progress Adequate
Application Number P150024 / PAS001
Study Name PATHWAY Clinical Trial PAS
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 Continued follow-up of premarket cohorts
Study Population Description Subjects who are active participants in the PATHWAY pivotal trial under G120045
Sample Size 46 subjects are currently enrolled in the study
Data Collection n/a
Follow-up Visits and Length of Follow-up 2 years post device explant

Bi-monthly for six months and at one and two years


PATHWAY Clinical Trial PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/13/2016 12/14/2016 Overdue/Received
one year report 06/14/2017 06/12/2017 On Time
18 month report 12/13/2017 12/12/2017 On Time
two year report 06/14/2018 06/12/2018 On Time
three year report 06/14/2019 06/12/2019 On Time
final report 07/29/2019 07/29/2019 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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