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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 P070014
Current Protocol Accepted 02/13/2009
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study will evaluate clinical outcomes on all patients enrolled (excluding those discontinued due to   show the rest ...
Study Population Description This device is indicated for improvement of luminal diameter in the treatment of symptomatic de-novo   show the rest ...
Sample Size 246 patients, 20 sites
Data Collection The Phase I primary safety endpoint was freedom from peri-procedural death, stroke, myocardial infarction, emergent   show the rest ...
Followup Visits and Length of Followup Post discharge clinical follow-up was performed at 1 month, 6 month and annually post-procedure out   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 246
Actual Number of Sites Enrolled 25
Patient Followup Rate 82%
Final Safety Findings There is no statistically significant difference in time to MACE between the test and control   show the rest ...
Final Effectiveness Findings The 36-month freedom from re-intervention and clinical success statistically favored the test group. The test   show the rest ...
Study Strengths and Weaknesses There was no statistical justification for the sample size and no specific hypotheses proposed for   show the rest ...
Recommendations for Labeling Changes Requested by ODE


Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 08/21/2009 08/31/2009 Overdue/Received
Final report 05/13/2010 05/12/2010 On Time

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