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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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Study Status Progress Adequate
Application Number P160043 / PAS002
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description RESOLUTE ONYX Post-Approval Study
Study Population Description Single arm study with Resolute Onyx Stent System
Sample Size 510 (up to 50 subjects may be enrolled prior to PMA approval)
Data Collection The primary endpoint is incidence of Target Lesion Failure (TLF) at 12 months, defined as Cardiac Death, Target Vessel MI or Target Lesion Resvascularization.
Follow-up Visits and Length of Follow-up 36 months
Interim or Final Data Summary
Interim Safety Information At 12 months (XLV cohort ITT Population): Target lesion Failure (TLF) was 10.9 (11/101) with 2- sided 95% CI of [5.6%, 18.7%]
At 24 months (XLV cohort ITT Population): Major Adverse Cardiac Event was 21.8% (22/101),
Cardiac death was 4.0% (4/101), clinically driven TVR 9.9% (10/101), clinically driven TLR was 8.9% (9/101), TLF 16.8% (17/101), target vessel failure 17.8% (18/101) and ARC definite Stent thrombosis 1.0% (1/101).
Actual Number of Patients Enrolled 101 subjects
Actual Number of Sites Enrolled 17
Patient Follow-up Rate 24-month follow-up visit compliance rate for XLV cohort - 90.3% (84/93)
Study Strengths & Weaknesses The follow-up rates through 2 years is approximately 90% at each time point. There is no formal hypothesis testing for the study results


Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 04/28/2018 04/26/2018 On Time
18 month report 10/28/2018 10/16/2018 On Time
2 year report 08/15/2019 08/14/2019 On Time
3 year report 04/27/2020 04/24/2020 On Time
4 year report 04/27/2021 04/23/2021 On Time
5 year report 04/27/2022 03/22/2022 On Time
6 year report 04/27/2023    

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