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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 P020026 S017
Current Protocol Accepted 10/10/2014
Study Name CYPHER MINI
Study Status Progress Adequate
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 Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a prospective, multi-center, non-randomized, postmarket surveillance study.
Study Population Description Study subjects with ischemic heart disease, due to stenotic lesions in either native coronary arteries   show the rest ...
Sample Size A total of 160 patients with de novo coronary artery lesions that are treatable with   show the rest ...
Data Collection Primary Endpoints



The primary endpoint of this study is target lesion failure (TLF) defined as clinically-driven   show the rest ...
Followup Visits and Length of Followup All subjects enrolled in this study will be followed for 33 months. Follow- up visits   show the rest ...


CYPHER MINI Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 09/18/2010 12/20/2010 Overdue/Received
2 year report 09/18/2011 09/19/2011 Overdue/Received
3 year report 09/17/2012 03/01/2013 Overdue/Received
4 year report 12/26/2013 12/23/2013 On Time
Final Report 01/10/2015    

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