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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-New Enrollment Argus II


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General
Application Number H110002 / PAS002
Current Plan Approved 09/18/2015
Study Name OSB Lead-New Enrollment Argus II
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description New Enrollment Post-Approval Study: Multicenter prospective cohort study with Argus II System. Several controls are incorporated into the study. Data collected in the study will be compared with pre-implantation (Baseline) data. In addition, prospective comparisons will be made between the implant and fellow eyes, and by testing subjects┬┐ visual performance with the Argus II System on and off.
Study Population Description Age 25 years or older; both males and females; with severe to profound retinitis pigmentosa; with bare or no light perception in both eyes or with retinal response to electrical stimulation; with previous history of useful form vision
Sample Size A total of 53 subjects will be enrolled in the study. It is anticipated that 85% of subjects will complete 5 years follow-up. This will provide a sample size of 45 subjects with complete 5 year follow-up. A minimum of 5 and a maximum of 40 centers in the US will participate in this study.
Data Collection Primary: Safety (i.e. adverse event rates), with the main safety analysis performed when all subjects have reached 2 years post-implant.

Secondary: Visual function, functional vision, and device reliability

Follow-up Visits and Length of Follow-up 5 years

Baseline, implant, month 1, 3, 6, 12, 24, 36, 48, 60.

Various follow-up assessments including medical and eye exam, functional evaluation will be tested at certain follow-up stages.



OSB Lead-New Enrollment Argus II 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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