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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.

Links

Contact Information

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

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General
Application Number P080006
Most Recent Protocol Version Approved 12/05/2013
Study Name Chronic Lead Performance
Study Status Progress Inadequate
Study Progress Reason Follow-up rate below 80%
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
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 This study utilizes the Medtronic¿s Post-Approval Network Product

Surveillance Registry (PSR) designed to conduct non-randomized, active   show the rest ...
Study Population Description The study will consist of patients rolled over from the pre-market study and patients newly   show the rest ...
Sample Size 1778 patients, 60 sites
Data Collection The endpoints include the complication free rate will be estimated based on the chronic (>   show the rest ...
Followup Visits and Length of Followup Patients will be followed every six months for 5 years


Chronic Lead Performance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
3 month report 07/21/2009 07/21/2009 On Time
9 month report 01/07/2010 01/06/2010 On Time
15 month report 07/07/2010 07/06/2010 On Time
21 month report 01/07/2011 12/22/2010 On Time
27 month report 07/07/2011 06/28/2011 On Time
33 month report 01/07/2012 12/22/2011 On Time
39 month report 07/07/2012 06/28/2012 On Time
45 month report 01/07/2013 01/04/2013 On Time
month report 08/09/2013 08/08/2013 Overdue/Received
51 month report 01/07/2014 01/08/2014 Overdue/Received
non-scheduled non-clinical report 04/14/2014 04/14/2014 On Time
63 month report 07/07/2014 06/26/2014 On Time
69 month report 01/07/2015    
75 month report 07/07/2015    
81 month report 01/07/2016    
Final Report 07/07/2016    

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