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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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AngelMed Guardian PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P150009 / PAS001
Date Original Protocol Accepted 08/14/2018
Date Current Protocol Accepted 05/19/2022
Study Name AngelMed Guardian PAS
Device Name Guardian System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Positive predictive value (PPV) and false positive rate (FPR) will be examined. Prospective, non-randomized, single arm, event-based, multi-center trail to assess device diagnostic accuracy, physician compliance, implantation expertise, emergency department physician experience, patient compliance for alerts, and training for prescribing, implanting, and emergency physicians, as well as patients. New subjects will be enrolled and a past study will be used as a control.
Study Population Patients with prior ACS events and high risk for recurrent ACS events.
Sample Size A minimum of 500 patients for the purpose of accruing 314 adjudicated true positive or false positive events.
Key Study Endpoints Co-primary endpoints include determination of PPV and FPR. Secondary endpoints include additional information: frequency of alarm-only ACS events (no signs of symptoms/discomfort), and the amount of time between patient symptom reports and medical presentation.
Follow-up Visits and Length of Follow-up Completion of follow-up study is anticipated by March 2023.
Interim or Final Data Summary
Interim Results Progress of study is adequate
Actual Number of Patients Enrolled 5
Actual Number of Sites Enrolled 12
Patient Follow-up Rate N/A. Subjects not far enough in for follow-up at time of report
Final Safety Findings N/A. Study is ongoing and progressing adequately
Final Effect Findings N/A. Study is ongoing and progressing adequately


AngelMed Guardian PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/08/2018 10/10/2018 Overdue/Received
1 year report 04/09/2019 04/01/2019 On Time
18 month report 10/08/2019 10/01/2019 On Time
2 year report 04/08/2020 04/01/2020 On Time
30 month report 10/08/2020 09/29/2020 On Time
3 year report 04/08/2021 04/08/2021 On Time
42 month report 10/08/2021 10/08/2021 On Time
4 year report 04/08/2022 04/25/2022 Overdue/Received
54 month report 10/20/2022 10/20/2022 On Time
5 year report 04/08/2023 04/26/2023 Overdue/Received
66 month report 10/08/2023 10/16/2023 Overdue/Received
6 year report 04/08/2024   Overdue


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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