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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Informed Decision Process


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General
Study Status Completed
Application Number P020056 / PAS006
Date Current Protocol Accepted 10/17/2006
Study Name Informed Decision Process
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Interim or Final Data Summary
Interim Safety Information There is no interim device safety Information from this study
Actual Number of Patients Enrolled The Informed Decision Process consisted of yearly surveys. Each year a different sample was selected for the survey. These are the results for 2011 annual report.

84 surveys were returned. Per the condition of approval, the sponsor did administer the survey to a random selection of 50 physicians.
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Final Safety Findings N/A
Final Effect Findings The majority (85.7%) of all respondents are satisfied with the Patient Planner, with 55.9% rating it Very Good and 29.8% rating it Good.
Study Strengths & Weaknesses The sample of physicians was chosen randomly, which is a strength of the study.

However, the observational, cross-sectional design of the study does not allow for any hypothesis testing. The results are descriptional only.
Recommendations for Labeling Changes Allergan is not currently proposing labeling changes based upon the survey results.


Informed Decision Process Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 year report 11/16/2008 11/13/2008 On Time
3 year report 11/16/2009 10/29/2009 On Time
4 year report 11/16/2010 10/29/2010 On Time
5 year report 11/16/2011 11/03/2011 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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