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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 P980035 S073
Most Recent Protocol Version Approved 05/13/2008
Study Name Longterm Study PAS
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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a 5-year, prospective, non-randomized, multi-center parallel study of implanted nEw3 (Adapta /Sensia/Versa)   show the rest ...
Study Population Description Study Population: All enrolled subjects have been implanted with a nEw3 device. Indication: The indications   show the rest ...
Sample Size At least 222 patients to ensure that at least 200 subjects are followed for 5   show the rest ...
Data Collection Medtronic CRDM considers a device as having malfunctioned whenever the analysis shows that any parameter   show the rest ...
Followup Visits and Length of Followup All subjects who are included in the analysis of the primary objective will continue to   show the rest ...


Longterm Study PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 11/13/2008 11/13/2008 On Time
1 year report 05/13/2009 05/13/2009 On Time
18 month report 11/11/2009 11/13/2009 Overdue/Received
2 year report 05/13/2010 05/13/2010 On Time
primary analysis report 03/30/2011 03/30/2011 On Time
3 year report 05/13/2011 05/13/2011 On Time
4 year report 05/12/2012 05/08/2012 On Time
5 year report 05/12/2013 05/09/2013 On Time
6 year report 05/12/2014 05/13/2014 Overdue/Received
7 year report 05/12/2015    
8 year report 05/11/2016    

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