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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-SFA ISR IDE Continued f/u study


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General
Study Status Progress Adequate
Application Number P130024 S009/ PAS002
Study Name ODE Lead-SFA ISR IDE Continued f/u 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 Continued follow-up
Study Population Description DCB
Data Collection the composite of freedom from all-cause peri-procedural (=30 day) death and freedom at 1 year and 2 years from index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death and (2) primary patency at 1 year and 2 years
Follow-up Visits and Length of Follow-up 3 years

yearly


ODE Lead-SFA ISR IDE Continued f/u study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
interim report 10/11/2017 10/11/2017 On Time
one year report 02/07/2018    
two year report 02/07/2019    
three year report 02/07/2020    
four year report 02/06/2021    
five year report 02/06/2022    


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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