Post-Approval Studies (PAS) Database

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

General
Study Status	Delayed
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
Interim Results	Safety Results Pads placed appropriately based on age: Yes (38), No (0) Patient mode appropriate selected: Yes (37), No (0), Unkown (1) Note: Pads were placed on participant 477011-004 but EMS arrived and removed AED before the device completed the startup process. This is the unknown subject. Effectiveness Results Appropriate shock energy delivered: Yes (8), No (0), No Shocks (29), Unkown (1) Note: Unknown is for the same reason as above.
Actual Number of Patients Enrolled	38
Actual Number of Sites Enrolled	Two study sties enrolled: 1) University of Buffalo (Buffalo, NY) 2) Colonie EMS (New York, NY)
Patient Follow-up Rate	N/A

AED 3 and Pad Placement PAS Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	08/28/2020	08/21/2020	On Time
1 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
54 month report	08/27/2024	08/22/2024	On Time
5 year report	02/27/2026

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background