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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 P080006 S004
Most Recent Protocol Version Approved 03/31/2011
Study Name Attain Ability Straight Model 4396
Study Status Progress Inadequate
Study Progress Reason 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 New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective Cohort Study
Study Population Description Inclusion Criteria

Subject or legally authorized representative provides written authorization and/or consent per institution and geographical   show the rest ...
Sample Size This study will consist of 1,016 patients implanted with Model 4396 lead enrolled from approximately   show the rest ...
Data Collection The primary objective of the PAS is to demonstrate that the Model 4396 lead-related complication-free   show the rest ...
Followup Visits and Length of Followup Subjects in the PAS will be followed for a minimum of 5 years from their   show the rest ...


Attain Ability Straight Model 4396 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 09/30/2011 09/28/2011 On Time
one year report 03/30/2012 03/26/2012 On Time
18 month report 09/29/2012 09/28/2012 On Time
two year report 03/30/2013 03/28/2013 On Time
30 month report 09/29/2013 09/27/2013 On Time
three year report 03/30/2014 03/25/2014 On Time
42 month report 09/29/2014 09/16/2014 On Time
four year report 03/30/2015    
54 month report 09/29/2015    
five year report 03/30/2016    

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