• 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...


             

OSB Lead-Impella RP Pediatric-RWE Eval and Report


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
Application Number P170011 / PAS002
Date Current Protocol Accepted  
Study Name OSB Lead-Impella RP Pediatric-RWE Eval and Report
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


OSB Lead-Impella RP Pediatric-RWE Eval and Report Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/21/2018    
one year report 09/20/2018    
18 month report 03/21/2019    
two year report 09/20/2019    
30 month report 03/20/2020    
Final Report 07/20/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

Related Links

-
-