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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-Cont f/u of PzF SHIELD IDE Cohort


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General
Study Status Study Pending
Application Number P160014 / PAS001
Study Name ODE Lead-Cont f/u of PzF SHIELD IDE Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket cohort
Study Population Description Single arm study with COBRA device
Sample Size 296 (already enrolled)
Data Collection The primary combined safety and effectiveness endpoint is the incidence of target vessel failure (TVF) within 270 days of treatment with the COBRA PzF™ Coronary Stent System. In-stent late lumen loss at 9 months post-implant is a powered secondary endpoint. These endpoints have already been met. Additional secondary endpoints include clinically driven target lesion revascularization and definite or probable stent thrombosis.
Follow-up Visits and Length of Follow-up 5 years

Annually


ODE Lead-Cont f/u of PzF SHIELD IDE Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 02/21/2018    
two year report 02/21/2019    
three year report 02/21/2020    
four year report 02/20/2021    
five year report 02/20/2022    


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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