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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 P030031 S011
Current Protocol Accepted 09/23/2011
Study Name OSB Lead-Atrial Fibrillation Registry
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 New Data Collection
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 study is a prospective, multicenter, non-randomized clinical evaluation of PAF patients treated with the   show the rest ...
Study Population Description Study Polulation: Adult patients with paroxysmal atrial fibrillation. Indication: For the treatment of paroxysmal atrial   show the rest ...
Sample Size 381 patietns, 109 in the more-experienced physician group and 272 in the less-experienced physician group,   show the rest ...
Data Collection The primary safety endpoints include adverse events that occur within 7 days of an ablation   show the rest ...
Followup Visits and Length of Followup Participants will be followed for 5-years.Participants will be asses prior to discharge, at the 1-month   show the rest ...

OSB Lead-Atrial Fibrillation Registry Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 mth report 02/12/2010 02/12/2010 On Time
1 year report 08/13/2010 08/13/2010 On Time
18 mth report 02/14/2011 02/14/2011 On Time
2 year report 08/12/2011 08/12/2011 On Time
3 year report 08/13/2012 08/08/2012 On Time
4 year report 08/12/2013 08/13/2013 Overdue/Received
5 year report 08/12/2014 08/08/2014 On Time
6 year report 08/12/2015 08/05/2015 On Time
7 year report 08/05/2016 08/05/2016 On Time

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