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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 P980049 S020
Most Recent Protocol Version Approved 04/28/2006
Study Name Ovatio DR6550 Study
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post-approval study is a 6-month, multi-center, single arm, prospective cohort study. All subjects in   show the rest ...
Study Population Description Study Population: Patients with an accepted indication for an implantable cardioverter defibrillator implant. Indication: The   show the rest ...
Sample Size 60 subjects at 5 sites
Data Collection Endpoints include incidence and nature of device related adverse events through 6 months follow-up (safety)   show the rest ...
Followup Visits and Length of Followup Patients will be evaluated at implant, 3 months, 6 months, and at unscheduled visits as   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 5
Actual Number of Sites Enrolled 77 successful implants (85 enrolled)
Patient Followup Rate 84.4% (65 patients completed study of 77 implanted)
Final Safety Findings There were 12 applicable system complications in 8 patients for a 6-month system complication free   show the rest ...
Final Effectiveness Findings Two successful reductions of VF occurred in 72 of the 77 implanted patients (93.5%; 95%   show the rest ...
Study Strengths and Weaknesses The purpose of the study was to follow at least 60 patients for 6 months   show the rest ...
Recommendations for Labeling Changes Yes


Ovatio DR6550 Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 10/27/2006 11/03/2006 Overdue/Received
1 year report 04/28/2007 04/27/2007 On Time
18 month report 10/27/2007 10/26/2007 On Time
2 year report 04/27/2008 04/18/2008 On Time
30 month report 10/27/2008 10/27/2008 On Time
3 year report 04/27/2009 04/29/2009 Overdue/Received
42 Month Report 10/27/2009 10/26/2009 On Time
Final Report 08/02/2010 08/02/2010 On Time

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