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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 P050019
Current Protocol Accepted 10/23/2008
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
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 BEACH Trial was a prospective, single-arm, multi-center trial intended to evaluate the safety and   show the rest ...
Study Population Description The Carotid WALLSTENT Monorail Endoprosthesis, used in conjunction with the Boston Scientific embolic protection system,   show the rest ...
Sample Size 747 patients, 47 sites
Data Collection The primary endpoint (defined as the composite of Non Q-wave myocardial infarction within the 24   show the rest ...
Followup Visits and Length of Followup Patients will be assessed at 30 days, and annually to 3 years.
Final Study Results
Actual Number of Patients Enrolled 747 patients
Actual Number of Sites Enrolled 47 sites
Patient Followup Rate 90%
Final Safety Findings The 3 year death, stroke and myocsrdial infarction rates were 5.6%, 2.3%, and 0.3%. These   show the rest ...
Study Strengths and Weaknesses Strengths: The sponsor did complete this study within a reasonable period of time (2 years   show the rest ...
Recommendations for Labeling Changes Labeling changes were not recommended.


Report Schedule
Date Due
FDA Receipt
Reporting Status
FINAL Report 04/23/2009 04/22/2009 On Time

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