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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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ABSORB IV Post-Approval Study


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General
Study Status Progress Adequate
Application Number P150023 / PAS001
Study Name ABSORB IV Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


ABSORB IV Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/03/2017 12/21/2016 On Time
one year report 07/05/2017 07/05/2017 On Time
3 yr clinical report 12/05/2017 12/05/2017 On Time
Primary Endpt Report 12/06/2017 12/06/2017 On Time
18 month report 01/03/2018 12/18/2017 On Time
two year report 07/05/2018 07/02/2018 On Time
ABSORB III RCT report 11/29/2018 11/29/2018 On Time
ABSORB IV RCT report 11/29/2018 11/29/2018 On Time
three year report 07/05/2019    
four year report 07/04/2020    
five year report 07/04/2021    


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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