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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 P070014 S022
Most Recent Protocol Version Approved 11/21/2011
Study Name LifeStent SOLO
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 New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multicenter, single- arm, non-randomized study.
Study Population Description Subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) in the infra-inguinal segment   show the rest ...
Sample Size Subjects will be enrolled at 25 study sites within the USA



A minimum of 234 subjects:   show the rest ...
Data Collection The Primary Safety endpoint is freedom from occurrence of death at 30-days and 12-months post-index   show the rest ...
Followup Visits and Length of Followup Subjects will be followed for 36 months

Subjects will undergo clinical assessments at 30 days, 12,   show the rest ...


LifeStent SOLO Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
report 02/13/2012 02/08/2012 On Time
two year report 02/13/2013 02/13/2013 On Time
three year report 02/13/2014 02/14/2014 Overdue/Received
four year report 02/13/2015    
five year report 02/13/2016    

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