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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Simulation Study of the AED 3 with CPR Uni-padz

General
Study Status	Delayed
Application Number / Requirement Number	P160015 S001/ PAS002
Date Original Protocol Accepted	07/16/2026
Date Current Protocol Accepted	10/16/2026
Study Name	Simulation Study of the AED 3 with CPR Uni-padz
Device Name	AED 3 defibrillator
General Study Protocol Parameters
Study Design	Other Study Design
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs

Simulation Study of the AED 3 with CPR Uni-padz Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
Final Report	06/15/2027

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