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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

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

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Application Number P890003 S179
Current Protocol Accepted 11/22/2013
Study Name OSB Lead-Chronic Lead Performance
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Medtronic Post-Approval Network (PAN) is designed to conduct non-randomized, active prospective post-market Surveillance. The   show the rest ...
Study Population Description This study will consist of 1,778 patients implanted with a DF-

4 connector system, enrolled at   show the rest ...
Sample Size Accounting for attrition, a minimum enrollment of 1778 DF4 connectors are estimated to be required   show the rest ...
Data Collection A list of lead-related events eligible to be included in the primary objective: Failure to   show the rest ...
Followup Visits and Length of Followup Subjects will be followed for a minimum of 5 years from their implant date. Therefore,   show the rest ...

OSB Lead-Chronic Lead Performance Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 07/09/2012 07/05/2012 On Time
one year report 01/08/2013 01/07/2013 On Time
18 month report 07/09/2013 07/08/2013 On Time
two year report 01/08/2014 01/09/2014 Overdue/Received
30 month report 07/09/2014 07/08/2014 On Time
three year report 01/08/2015 01/07/2015 On Time
42 month report 07/09/2015 07/08/2015 On Time
four year report 01/08/2016 01/07/2016 On Time
54 month report 07/08/2016 07/07/2016 On Time
five year report 01/07/2017    
66 month report 07/08/2017    

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