• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • 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...


Lutonix Long Lesion SFA Cont f/u study

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Progress Adequate
Application Number P130024 S009/ PAS003
Study Name Lutonix Long Lesion SFA Cont f/u study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up
Study Population Description DCB
Data Collection the composite of freedom from all-cause peri-procedural (=30 day) death and freedom at 1 year and2 years from the following: index limb amputation and (above or below the ankle) and index limb re-intervention and (2) primary patency at 1 year and 2 years
Follow-up Visits and Length of Follow-up 2 years


Lutonix Long Lesion SFA Cont f/u study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 02/07/2018 03/07/2018 Overdue/Received
two year report 02/07/2019    
three year report 02/07/2020    
four year report 02/06/2021    
five year report 02/06/2022    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

Related Links