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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 P020018 S005
Most Recent Protocol Version Approved 06/09/2005
Study Name Postmarket Surveillance Registry
Study Status Completed
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 Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Renu registry was designed as a non-randomized, single arm, prospective, postmarket registry of cases   show the rest ...
Study Population Description The Zenith Renu AAA Ancillary Graft from Cook Incorporated is indicated for secondary endovascular intervention   show the rest ...
Sample Size 100 patients, no site limit specified
Data Collection Endpoints include: 1) Post-procedure (within 30 days of the procedure) rate of rupture and subsequent   show the rest ...
Followup Visits and Length of Followup Data will be collecte pre-procedure, post-procedure within 30 days, at 12 months with clinical and   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 151
Actual Number of Sites Enrolled 95
Patient Followup Rate 60%
Final Safety Findings One case of Renu migration occurred at 36 months after implantation. One occlusion was identified   show the rest ...
Final Effectiveness Findings One hundred eleven (111) cases (73.5%) were identified with endoleaks prior to or during the   show the rest ...
Study Strengths and Weaknesses The sponsor reports that 91 patients reached an endpoint at 5 years. Although the follow-up   show the rest ...
Recommendations for Labeling Changes Yes. The labeling supplement should include a summary of the post-approval study design, results, and   show the rest ...


Postmarket Surveillance Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
3 month registry report 09/08/2005 11/17/2005 Overdue/Received
6 month registry report 12/08/2005 01/18/2006 On Time
9 month registry report 03/09/2006 04/10/2006 Overdue/Received
1 year registry report 06/09/2006 07/13/2006 Overdue/Received
15 month registry report 09/08/2006 10/10/2006 Overdue/Received
18 month report 12/08/2006 01/10/2007 Overdue/Received
2 year report 06/09/2007 06/07/2007 On Time
3 year report 06/08/2008 06/03/2008 On Time
4 year report 06/08/2009 06/04/2009 On Time
5 year report 06/08/2010 05/27/2010 On Time
Final report 02/28/2011 02/28/2011 On Time

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