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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 P100046
Current Protocol Accepted 06/13/2014
Study Name AtriCure Synergy Ablation System
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center, observational, single arm registry study.
Study Population Description Subjects who are at least 18 years old, have non-paroxysmal forms of atrial fibrillation, are   show the rest ...
Sample Size The sample size of 350 subjects obtained from 50 different U.S. sites is driven by   show the rest ...
Data Collection Main Endpoints

Safety: Serious device and procedure-related adverse events (not including pacemaker implantation) at one   show the rest ...
Followup Visits and Length of Followup 3 years post-procedure

Clinical follow-up will be at 30 days, 4 months, and 1, 2,   show the rest ...


AtriCure Synergy Ablation System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 06/14/2012 06/15/2012 Overdue/Received
one year report 12/13/2012 12/12/2012 On Time
18 month report 06/13/2013 06/13/2013 On Time
two year report 12/13/2013 12/16/2013 Overdue/Received
three year report 12/13/2014   Overdue
four year report 12/13/2015    
five year report 12/12/2016    

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