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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Ext f/u of the Argus II Feasibility Study


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General
Application Number H110002 / PAS001
Current Plan Approved 02/13/2013
Study Name OSB Lead-Ext f/u of the Argus II Feasibility Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Extending the Single-armed feasibility study
Study Population Description Subjects who have completed participation in the Investigational Phase of this study and who have the Argus II device still implanted are eligible for enrollment in the Post-Approval Phase of this study.
Sample Size N = 29. Fourteen (14) subjects were enrolled in the Investigational Phase of the study. One of these 14 subjects was explanted, which leaves a maximum of 13 subjects in the U.S. eligible for the post-approval phase of this study. An additional 16 subjects were enrolled in a similar study in Europe. All 16 of these subjects are eligible for participation in the post-approval phase of the study.
Data Collection The primary endpoint of the post-approval phase is safety (i.e. the rates of adverse events). The secondary endpoint of the post-approval phase the long-term reliability of the Argus II implant.
Follow-up Visits and Length of Follow-up Extend the subjects¿ overall participation in the study to 10 years post-implant.

During year 5 to 7, every six month; from year 8 to 10 annually. Note the examinations are not exactly the same prior to year 7 and thereafter, because the study undergoing was extended to year 7.



OSB Lead-Ext f/u of the Argus II Feasibility Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/14/2013 08/14/2013 On Time
one year report 02/13/2014 02/11/2014 On Time
18 month report 08/14/2014 08/18/2014 Overdue/Received
two year report 02/13/2015 02/13/2015 On Time
three year report 02/13/2016 02/16/2016 Overdue/Received
four year report 02/12/2017    
five year report 02/12/2018    


Contact Us

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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