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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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ODE Lead-RESOLUTE ONYX PAS


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General
Study Status Study Pending
Application Number P160043 / PAS002
Study Name ODE Lead-RESOLUTE ONYX PAS
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 410 (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


ODE Lead-RESOLUTE ONYX PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 04/28/2018    
two year report 04/28/2019    
three year report 04/27/2020    
four year report 04/27/2021    
five year report 04/27/2022    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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