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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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Cont F/u of HW004-A ENDURANCE

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Study Status Progress Adequate
Application Number P100047 S090/ PAS001
Date Current Protocol Accepted 08/06/2018
Study Name Cont F/u of HW004-A ENDURANCE
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
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 This study was designed to evaluate longer-term safety and effectiveness outcomes of patients receiving an HVAD for Destination Therapy through continued follow-up of all living subjects who were enrolled in the ENDURANCE Supplemental trial under G090243.
Study Population Description All subjects who were enrolled in the ENDURANCE Supplemental trial and alive at 12 months post-original implant.
Sample Size All subjects who were alive at 12 months post-original implant are eligible for continued follow-up.
Data Collection Subjects will be followed out to five years post-original implant and descriptive data will be collected in accordance with the protocol.
Follow-up Visits and Length of Follow-up 5 years post-original implant procedure

Cont F/u of HW004-A ENDURANCE Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 03/28/2018 04/24/2018 Overdue/Received
one year report 11/08/2018 11/13/2018 Overdue/Received
18 month report 03/28/2019 03/28/2019 On Time
two year report 09/27/2019 09/30/2019 Overdue/Received
final report 01/07/2021 01/07/2021 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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