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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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AED 3 and Pad Placement PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P160015 S001/ PAS001
Date Original Protocol Accepted 06/05/2020
Date Current Protocol Accepted  
Study Name AED 3 and Pad Placement PAS
Device Name AED 3 defibrillator
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective, observational study
Study Population Patients found in out-of-hospital cardiac arrest and receiving attempted resuscitation with a ZOLL AED 3 equipped with Uni-padz
Sample Size Approximately 73 adult subjects and 15 pediatric subjects
Key Study Endpoints Study endpoints include appropriate placement of the electrodes which will be assessed by EMS personnel based on observations made when they arrive on scene, the appropriate selection of adult or pediatric mode which will be assessed by identifying that the child button was pressed when the estimated age is less than 8 years old, and the delivery of defibrillation energy which will be determined by documented whether the energy was age-appropriate if a shock was delivered.
Follow-up Visits and Length of Follow-up Subjects will not be followed after the assessment of study objectives
Interim or Final Data Summary
Actual Number of Patients Enrolled The sites have enrolled 36 participants to-date (33 at University of Buffalo, 3 at Colonie)
Actual Number of Sites Enrolled There are currently three sites:
1. The University at Buffalo (UB), initiated on March 30, 2021.
2. Colonie EMS (New York) was initiated as the second study site on December 19th, 2022, though no participants have been enrolled at this site. 3. University at Buffalo initiated on 10/31/2023
Current IRB approvals for all sites are provided as Attachments 1 and 2 of the submission
Patient Follow-up Rate Date of study follow-up completion: February 2024.
Study Strengths & Weaknesses N/A


AED 3 and Pad Placement PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/28/2020 08/21/2020 On Time
one year report 02/27/2021 03/01/2021 Overdue/Received
18 month report 08/28/2021 08/25/2021 On Time
2 year report 02/27/2022 02/25/2022 On Time
3 year report 02/27/2023 02/27/2023 On Time
4 year report 02/27/2024 02/14/2024 On Time
final report 08/27/2024    


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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