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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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Impella AMI CS PAS

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Study Status Progress Adequate
Application Number P140003 S004/ PAS001
Date Current Protocol Accepted 07/13/2021
Study Name Impella AMI CS PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of the study is to evaluate the safety and
effectiveness of Impella devices in a real world representative population through the cVAD registry.

The study design is an observation, prospective and retrospective, multicenter, and single cohort clinical investigation of patients supported with Impella devices for the indication of AMICS with revascularization and enrolled in the cVAD registry.
Study Population Description Patients (> 18 years old) supported with Impella devices (Impella
2.5, CP, 5.0 or LD) for the indication of acute myocardial infarction (AMICS) with revascularization and enrolled in the
cVAD registry at U.S. institutions after the PMA post market study approval will be considered eligible for the post-approval study. Patients will be enrolled consecutively without interruption at all participating sites without preselection.
Sample Size A minimum of 276 participants will be evaluated to compare the survival rate at 30 days or discharge, whichever is longer, to a performance goal of 34%. It is estimated that 304 participants will be enrolled, assuming 10% loss to follow-up to 30 days post- procedure.
Data Collection Primary endpoint:
Survival rate at 30 days or discharge, whichever is longer

Secondary endpoints:
Adverse event rates to 30 days or discharge whichever is longer The technical success rate and device (implant) success rate at exit from catheterization laboratory or operation room.
Follow-up Visits and Length of Follow-up 1 year post implant
30 days, 90 days, 1 year post implant follow ups

Impella AMI CS PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 10/06/2016 10/07/2016 Overdue/Received
1 year report 04/07/2017 04/24/2017 Overdue/Received
18 month report 10/06/2017 10/06/2017 On Time
2 year report 04/07/2018 04/03/2018 On Time
3 year report 05/07/2019 05/07/2019 On Time
4 year report 04/07/2020 04/06/2020 On Time
5 year report 04/07/2021 04/05/2021 On Time
final report 06/15/2022 06/15/2022 On Time

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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