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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 P050025
Most Recent Protocol Version Approved 10/12/2006
Study Name SONOMA
Study Status Other
Study Progress Reason Device not marketed
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 Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This was a nonrandomized, open-label study intended to confirm the safety of the NexStent

Carotid Stent   show the rest ...
Study Population Description Study Population: Patients with neurological systems associated with >50% stenosis of the common or internal   show the rest ...
Sample Size 1650 patients, number of sites not specified
Data Collection The primary endpoints included 30-day rate of major adverse events defined as all deaths, strokes,   show the rest ...
Followup Visits and Length of Followup Though 1,650 subjects were planned for the SONOMA study, only 298 had been enrolled at   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 298 patients
Actual Number of Sites Enrolled 62 sites
Patient Followup Rate 88%
Final Safety Findings The sponsor voluntarily recalled this device in June of 2008 due to complaints involving detachment   show the rest ...
Study Strengths and Weaknesses Strengths: Post approval study aided in uncovering problem with stent delivery. Weaknesses: There was no   show the rest ...
Recommendations for Labeling Changes Not applicable, stent no longer marketed.


SONOMA Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 10/27/2007 10/29/2007 Overdue/Received
Interim Report 10/27/2008 10/27/2008 On Time
Final Report 03/31/2010 03/05/2010 On Time

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