f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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ISR and LL Cohorts of the Global SFA Reg


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General
Study Status Completed
Application Number /
Requirement Number		 P130024 S009/ PAS001
Study Name ISR and LL Cohorts of the Global SFA Reg
Device Name LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Registry
Study Population DCB
Key Study Endpoints the composite of freedom from all-cause peri-procedural (=30 day) death and freedom at 1 year and 2 years from: index limb amputation, index limb re-intervention, and index limb death and (2) freedom from TLR at 1 year and 2 years
Follow-up Visits and Length of Follow-up 2 years
yearly


ISR and LL Cohorts of the Global SFA Reg Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 10/11/2017 10/11/2017 On Time


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

Additional Resources

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