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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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ABSORB IV Post-Approval Study

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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
Detailed Study Protocol Parameters
Study Design Description Study Objective
Evaluate the safety of the use of Absorb in a real-world setting following commercial physician training
Observe the effectiveness of commercial physician training on appropriate vessel sizing in the use of Absorb in a real-world setting

Study Design
Prospective, open-label, multi-center, single-arm, non-randomized trial designed to observe Absorb continued safety during commercial use in real world settings.
Study Population Description Full Analysis Set (FAS): All subjects registered in the study.
Absorb Only Population (AOP): Subjects who have had only Absorb study devices implanted.
Pooled Absorb Population (PAP): Subjects from the ABSORB Post-Approval Clinical Study and ABSORB IV trial. The ABSORB PAS is projected to enroll approximately 75% ABSORB IV-like subjects (approximately N=1500), this will be pooled with approximately N=1500 Absorb subjects from the ABSORB IV trial.
Sample Size Approximate 2000 subjects total
Data Collection Primary Endpoint
The powered primary endpoint of the ABSORB Post-Approval Study trial is the composite of cardiac death and myocardial infarction (CD/MI) at 1 year. MI is adjudicated per the Universal MI definition.

Major Secondary Endpoint
The major secondary endpoint is definite/probable scaffold thrombosis (per ARC definition) at 1 year.

Other Endpoints:

Commercial Training Assessment Endpoint (Angiographic Subgroup only)
Percentage of very small vessels*
Clinical Endpoints – evaluated in hospital and at each follow-up time point
Component and Other Clinical Endpoints
Death (Cardiac, Non-Cardiac)
All Myocardial Infarction (All MI)
Target Lesion Revascularization (TLR)
Ischemia Driven TLR (ID-TLR)
Target Vessel Revascularization (TVR)
All coronary revascularization
Scaffold thrombosis (per ARC definition)
Composite Endpoints
Death/All MI
Cardiac Death/All MI
Cardiac Death/All MI/TVR (Target Vessel Failure, TVF)
Cardiac Death/TV MI/ID-TLR (TLF)
Death/All MI/All revascularization

ABSORB IV Post-Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
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
interim report 12/05/2017 12/05/2017 On Time
Interim 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
interim report 11/29/2018 11/29/2018 On Time
interim report 11/29/2018 11/29/2018 On Time
three year report 07/05/2019 07/03/2019 On Time
interim report 11/13/2019 11/13/2019 On Time
5 year report 11/13/2019 11/13/2019 On Time
3 year interim report 11/15/2019 11/15/2019 On Time
4 year report 07/04/2020 06/30/2020 On Time
3 year report 11/14/2020 11/04/2020 On Time
5 year report 07/04/2021 07/01/2021 On Time
interim report 10/18/2021 10/18/2021 On Time
6 year report 11/04/2022    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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