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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 US Enrollment


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General
Application Number P100022 / PAS001
Current Plan Approved 02/15/2013
Study Name OSB Lead-New US Enrollment
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description A prospective, single-arm, multicenter study of newly enrolled U.S. patients.
Study Population Description Patients with symptomatic vascular disease of the native above-the-knee femoro-popliteal arteries with a reference vessel diameter 4- 7 mm and total lesion lengths up to 140 mm per limb and 280 mm total.

The study has no control group. The comparator is performance goal of

83.1% at 1 year.

Sample Size 200 new patients enrolled from a minimum of 10 sites across the United

States.

Data Collection Primary Endpoint: Target lesion Revascularization (TLR) at 1 year. Secondary Endpoints: thrombosis, stent fracture other adverse events.
Follow-up Visits and Length of Follow-up 1 year

TLR assessment at 1 year.

Stent thrombosis and other adverse events assessments at pre-discharge and 1 year.



OSB Lead-New US Enrollment Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/15/2013 05/14/2013 On Time
one year report 11/14/2013 11/14/2013 On Time
18 month report 05/15/2014 05/14/2014 On Time
two year report 11/14/2014 11/13/2014 On Time
three year report 11/14/2015 11/13/2015 On Time
updated report 12/07/2015 12/07/2015 On Time
four year report 11/13/2016    
five year report 11/13/2017    


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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