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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 P110042
Current Protocol Accepted 09/28/2012
Study Name OSB Lead-S-ICD PAS Registry
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
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 Prospective cohort study
Study Population Description Any patient, who meets the inclusion criteria, does not meet the exclusion criterion and provides   show the rest ...
Sample Size 1616 patients from approximately 50 investigational centers (up to 150) in the US
Data Collection The primary safety endpoint of the study is the Type I Complication Free Rate at   show the rest ...
Followup Visits and Length of Followup Data will be collected through the 60th month (1800 days) post implant.

Data will be collected   show the rest ...

OSB Lead-S-ICD PAS Registry Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 03/29/2013 03/27/2013 On Time
one year report 09/28/2013 09/26/2013 On Time
18 month report 03/29/2014 03/26/2014 On Time
two year report 10/06/2014 10/01/2014 On Time
three year report 09/28/2015 09/25/2015 On Time
four year report 09/27/2016    
five year report 09/27/2017    

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