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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 P060006
Current Protocol Accepted 12/11/2008
Study Name BSC Express PAS
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 Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Renaissance study is a prospective, multi-center, single-arm study for use of the Express Renal   show the rest ...
Study Population Description The Boston Scientific Express SD Renal Monorail Premounted Stent System is indicated as an adjunct   show the rest ...
Sample Size 100 subjects with 117 lesions, the number of sites not reported
Data Collection The primary endpoint is binary in-stent restenosis rate of the Express Renal Stent at nine   show the rest ...
Followup Visits and Length of Followup All subjects will be evaluated at 30 days, 4 months, 9 months, and annually for   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 100 patients
Actual Number of Sites Enrolled Not reported
Patient Followup Rate 82%
Final Safety Findings No serious, device-related events that were unanticipated in nature, frequency or severity occurred during the   show the rest ...
Study Strengths and Weaknesses Strengths: Overall follow-up was 81.5% of eligible subjects returning for 5-year follow-up. Weaknesses: There was   show the rest ...
Recommendations for Labeling Changes There were no recommendations for changes to the labeling based on the results of the   show the rest ...


BSC Express PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 06/11/2009 06/16/2009 Overdue/Received
Final Report 12/11/2009 12/09/2009 On Time

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