f Post-Approval Studies (PAS) Database
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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...


           

ABSORB USA Post Approval Clinical Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Terminated
Application Number /
Requirement Number		 P150023 / PAS002
Date Original Protocol Accepted 10/10/2017
Date Current Protocol Accepted  
Study Name ABSORB USA Post Approval Clinical Study
Device Name ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
General Study Protocol Parameters


ABSORB USA Post Approval Clinical Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/03/2017 05/15/2017 Overdue/Received
one year report 07/05/2017 07/05/2017 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

Additional Resources

-
-