f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail

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.

Learn more...


Impella Real World Surveillance

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Study Pending
Application Number /
Requirement Number
P170011 S035/ PAS001
Date Original Protocol Accepted 08/18/2022
Date Current Protocol Accepted  
Study Name Impella Real World Surveillance
Device Name Impella RP System, Impella RP with SmartAssist System
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source Sponsor Registry
Comparison Group Concurrent & Historical Control
Study Population Adult: >21

Impella Real World Surveillance Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 04/19/2023    
2 year report 04/18/2024    
3 year report 04/18/2025    
4 year report 04/18/2026    

Contact Us

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

Additional Resources