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

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Ext f/u of the Argus II Feasibility Study

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Study Status Progress Adequate
Application Number H110002 / PAS001
Date Current Protocol Accepted 02/13/2013
Study Name 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.

Interim or Final Data Summary
Interim Safety Information A total of 30 subjects have been enrolled with an implant average implant average of 10.39 +/- 2.84 years (range 1.2 – 12.6 years). Of these, twenty-four subjects have completed full study participation (10 years) and one subject withdrew prior to completing study participation. Four (4) subjects in the study had the Argus II device explanted. The average post-explant duration is 6.6 +/- 4.0 years (range 1.6 – 11.4 years). None unanticipated adverse device events reported.
Actual Number of Patients Enrolled 30 subjects
Actual Number of Sites Enrolled 10
Patient Follow-up Rate 82.8%
Study Strengths & Weaknesses This information will be included in the final report

Ext f/u of the Argus II Feasibility Study Schedule

Report Schedule
Date Due
FDA Receipt
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 02/06/2017 On Time
five year report 02/12/2018 02/13/2018 Overdue/Received
six year report 02/12/2019 02/11/2019 On Time
seven year report 02/12/2020 02/14/2020 Overdue/Received
final report 06/12/2020   Overdue

Contact Us

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

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