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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 P010031 S344
Current Protocol Accepted 09/25/2013
Study Name LIA in Non-MDT Leads Surveillance Update Analysis
Study Status Completed
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This analysis plan is created to leverage data that is already available as part of   show the rest ...
Study Population Description This is a retrospective analysis of existing data from CareLink. Among the large number of   show the rest ...
Sample Size As there are no hypotheses being tested for this analysis, there are no powered sample   show the rest ...
Data Collection There are three Medtronic sources of information that will be used to support this analysis:

? Data   show the rest ...
Followup Visits and Length of Followup No follow-up visits and length of follow-up
Final Study Results
Actual Number of Patients Enrolled 5753 devices
Actual Number of Sites Enrolled N/A
Patient Followup Rate N/A
Final Safety Findings N/A
Final Effectiveness Findings The incidence of right ventricular (RV) Lead Integrity Alert (LIA) trigger or impedance nominal threshold   show the rest ...
Study Strengths and Weaknesses Strength: Large sample size;

Weakness: Retrospective data analysis. Lack of data presented to support advance warning   show the rest ...
Recommendations for Labeling Changes No


LIA in Non-MDT Leads Surveillance Update Analysis Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report-FINAL 03/26/2014 03/05/2014 On Time
one year report 09/25/2014   Overdue
18 month report 03/26/2015    
two year report 09/25/2015    
three year report 09/24/2016    
four year report 09/24/2017    
five year report 09/24/2018    

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