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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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ODE Lead Post-Approval Study


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General
Study Status Progress Inadequate
Application Number P150034 / PAS001
Date Current Protocol Accepted 02/15/2018
Study Name ODE Lead Post-Approval 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 This study is a new enrollment and continued follow-up of a single-arm, prospective, multicenter study to evaluate the long term safety of the Raindrop® Near Vision Inlay implanted in an emmetropic population (continued follow-up of premarket cohort). All subjects who meet the inclusion criteria will be followed over a 60-month period or 24 months post inlay removal.
Study Population Description Not applicable for this study as this is a continuation study of the IDE cohort and continued enrollment of about 75 subjects per month.
Sample Size Not applicable for this study as this is a continuation study of the IDE cohort.
Data Collection 1. Preservation of best corrected visual acuity

2. Incidence of secondary surgical interventions

Follow-up Visits and Length of Follow-up 60-months

Follow-ups at 1 day, 1 month, 6 months, 12 months, and 24 months. For subjects that have not had inlay removed then examinations will also occur at 48 months and 60 months.


ODE Lead Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/28/2016 01/23/2017 Overdue/Received
one year report 06/29/2017 06/28/2017 On Time
18 month report 01/31/2018 02/01/2018 Overdue/Received
two year report 06/29/2018    
three year report 06/29/2019    
four year report 06/28/2020    
five year report 06/28/2021    


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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