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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 P030054 S130
Current Protocol Accepted 05/04/2010
Study Name QuickFlex u Model 1258T LV lead
Study Status Progress Adequate
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 This study is designed to characterize the chronic performance of the St. Jude Medical QuickFlex®   show the rest ...
Study Population Description Study Population: Patients with an approved indication, as per cardiovascular society guidelines, for implantation of   show the rest ...
Sample Size 1884 patients, 80 sites
Data Collection Complication free survival rate at 5 years for complications related to the RV lead or   show the rest ...
Followup Visits and Length of Followup Patients will be followed every six months for 5 years


QuickFlex u Model 1258T LV lead Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 11/08/2010 11/12/2010 Overdue/Received
one year report 05/10/2011 05/10/2011 On Time
18 month report 11/08/2011 11/09/2011 Overdue/Received
2 year report 05/09/2012 05/10/2012 Overdue/Received
30 month report 11/09/2012 11/13/2012 On Time
3 year report 05/09/2013 05/14/2013 Overdue/Received
42 month report 11/09/2013 11/12/2013 Overdue/Received
4 year report 05/09/2014 05/07/2014 On Time
54 month report 11/09/2014   Overdue
5 year report 05/09/2015    

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