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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 P960040 S198
Most Recent Protocol Version Approved 01/14/2011
Study Name Longitudinal Surveillance Study
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) 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 LSS of 4-SITE is a prospective, nonrandomized, multi-center registry of patients implanted with the   show the rest ...
Study Population Description Patients implanted with the 4-SITE Lead/Header system
Sample Size 1,780 patients.(assuming an annual attrition rate of 10%, a minimum of 1,780 patients implanted with   show the rest ...
Data Collection For the 4-SITE Lead/Header system, the primary endpoint for this registry will evaluate the proportion   show the rest ...
Followup Visits and Length of Followup Five-years post implant

Every six months


Longitudinal Surveillance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 05/11/2011 05/05/2011 On Time
one year report 11/10/2011 11/02/2011 On Time
18 month report 05/10/2012 05/08/2012 On Time
two year report 11/09/2012 11/09/2012 On Time
30 month report 05/10/2013 05/06/2013 On Time
three year report 11/09/2013 11/07/2013 On Time
42 month report 05/10/2014    
four year report 11/09/2014    
54 month report 05/10/2015    
five year report 11/09/2015    
66 month report 05/09/2016    
six year report 11/08/2016    

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