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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 P060039
Current Protocol Accepted 09/12/2014
Study Name OSB Lead-Chronic Extraction
Study Status Completed
General Study Protocol Parameters
Study Design Case Control Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this study is to characterize the removability of the Attain StarFixModel 4195   show the rest ...
Study Population Description The Attain StarFix Model 4195 steroid eluting, transvenous lead with deployable lobe fixation is intended   show the rest ...
Sample Size 120 study subjects (Model 4195 and non-Model 4195 implanted subjects) will be enrolled in the   show the rest ...
Data Collection The primary objective of the study is to compare the removal success of the Model   show the rest ...
Followup Visits and Length of Followup Subjects will be followed at one month after extraction attempt. The one month follow-up can   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 227 subjects
Actual Number of Sites Enrolled 24 centers
Patient Followup Rate 89.77%
Final Safety Findings Extraction success is either: 1) removal of all targeted leads and all lead material from   show the rest ...
Final Effectiveness Findings NA
Study Strengths and Weaknesses Strength: The high follow-up rate: 89.77%

Weaknesses: Limited number of leads studied: 40 Model 4195 leads

  show the rest ...
Recommendations for Labeling Changes Yes (Labeling updates has been approved in P060039/S056)

OSB Lead-Chronic Extraction Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 07/28/2009 07/28/2009 On Time
1 year report 02/02/2010 02/02/2010 On Time
18 month report 07/28/2010 07/28/2010 On Time
24 month report 01/28/2011 01/27/2011 On Time
3 year report 08/13/2011 07/28/2011 On Time
42 month report 02/12/2012 02/02/2012 On Time
4 year report 08/12/2012 08/10/2012 On Time
54 month report 02/11/2013 02/11/2013 On Time
5 year report 08/12/2013 08/12/2013 On Time
66 month report 02/11/2014 02/14/2014 Overdue/Received
72 month report 08/13/2014 08/13/2014 On Time
Final Report 12/12/2014 12/11/2014 On Time

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