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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 P010012 S160
Current Protocol Accepted 06/25/2009
Study Name OSB Lead - ACUITY Long-Term Registry
Study Status Progress Inadequate
Study Progress Reason Site enrollment milestones not met, Subject enrollment milestones not met
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 Objective Performance Criterion
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description prospective, non-randomized, multi-center registry
Study Population Description The study population will consist of patients who: were successfully implanted with the ACUITY Spiral   show the rest ...
Sample Size 1,700 patients, 150 sites
Data Collection Chronic LV lead-related complication-free rate over a five year follow- up period
Followup Visits and Length of Followup Patients will be followed until they have completed five years of

follow-up from implant or until   show the rest ...

OSB Lead - ACUITY Long-Term Registry Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
18 month report 11/14/2009 11/13/2009 On Time
2 year report 05/16/2010 05/14/2010 On Time
30 month report 11/14/2010 11/15/2010 Overdue/Received
3 year report 05/16/2011 05/12/2011 On Time
42 month report 11/14/2011 11/14/2011 On Time
4 year report 05/15/2012 05/15/2012 On Time
54 month report 11/13/2012 11/13/2012 On Time
5 year report 05/15/2013 05/13/2013 On Time
interim report 11/13/2013 11/07/2013 On Time
6 year report 05/15/2014 05/05/2014 On Time
78 month report 11/15/2014 11/13/2014 On Time
7 year report 05/15/2015 05/12/2015 On Time
interim report 11/15/2015 11/04/2015 On Time
8 year report 07/14/2016 06/27/2016 On Time
102 month report 11/14/2016    
9 year report 05/14/2017    

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