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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.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P890003 S119
Current Protocol Accepted 05/13/2008
Study Name OSB Lead-Longterm 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 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 ...
Final Study Results
Actual Number of Patients Enrolled 2927
Actual Number of Sites Enrolled 132
Patient Followup Rate 75.23%
Final Safety Findings The 5-year device survival probability was 100.0%, with 95% CI (99.7%, 100.0%).
Final Effectiveness Findings N/A
Study Strengths and Weaknesses 1) large sample size of 2927 subjects

2) long-term follow-up for 5 years

Weakness: 1) study deviation   show the rest ...
Recommendations for Labeling Changes No

OSB Lead-Longterm PAS Schedule

Report Schedule
Date Due
FDA Receipt
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  
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 05/13/2015 Overdue/Received
Final Report 05/11/2016 01/08/2016 On Time

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