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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 P040043
Current Protocol Accepted 08/31/2005
Study Name Training Study
Study Status Completed
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 No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an observational, multi-site, one armed prospective cohort study of patients with aneurysms treated   show the rest ...
Study Population Description The study will enroll subjects diagnosed with aneurysm of the DTA who meet all inclusion/exclusion   show the rest ...
Sample Size 150 patients from 25 sites
Data Collection The incidence of major adverse events at 30 days post-implant. Major Adverse Event are defined   show the rest ...
Followup Visits and Length of Followup Patients are evaluated at 30 days post-implant.
Final Study Results
Actual Number of Patients Enrolled 150 patients
Actual Number of Sites Enrolled 25 sites
Patient Followup Rate 100%
Final Safety Findings All success criteria were met
Study Strengths and Weaknesses Strength: Very good patient follow-up; Data collection was complete
Recommendations for Labeling Changes None


Training Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
4 year report 03/22/2009 03/25/2009 Overdue/Received

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