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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 Progress Adequate
Application Number P160015 S001/ PAS001
Date Current Protocol Accepted  
Study Name AED 3 and Pad Placement PAS
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 Design Description The purpose of this PAS is to confirm the safety and effectiveness of the Uni-padz used with the ZOLL AED 3 device in a real-world setting. This is a prospective, observational study.

Objectives:

(3) Demonstrate appropriate CPR sensor placement on pediatric and adult patients

(4) Demonstrate delivery of appropriate energy level shocks to pediatric and adult patients
Study Population Description 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
Data Collection Main Safety Endpoint: The appropriateness of placement of the CPR sensor in pediatric and adult patients

Main Effectiveness Endpoint: The delivery of an appropriate energy level shock to pediatric and adult patients
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 N/A
Actual Number of Sites Enrolled 1
Patient Follow-up Rate N/A
Study Strengths & Weaknesses N/A


AED 3 and Pad Placement PAS Schedule

Report 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    
3 year report 02/27/2023    
4 year report 02/27/2024    
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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