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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-LifeStent SOLO

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Application Number P070014 S022/ PAS001
Current Plan Approved 07/11/2014
Study Name OSB Lead-LifeStent SOLO
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multicenter, single- arm, non-randomized study.
Study Population Description Subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) in the infra-inguinal segment and/or proximal popliteal artery that are amenable to PTA and stenting.

The control group is historical cohorts of RESILIENT PTA group

Sample Size Subjects will be enrolled at 25 study sites within the USA

A minimum of 234 subjects: at least 64 subjects with target lesion lengths < 160 mm; at least 64 subjects with target lesion lengths > 160 mm and < 240 mm and at least 64 subjects treated with the 200 mm LifeStent will be enrolled.

Data Collection The Primary Safety endpoint is freedom from occurrence of death at 30-days and 12-months post-index procedure.

The Primary Effectiveness is device success defined as freedom from acute delivery failure, and primary target lesion patency (TLP) at 12 months post index procedure.

Freedom from Fracture (FFF)

Follow-up Visits and Length of Follow-up Subjects will be followed for 36 months

Subjects will undergo clinical assessments at 30 days, 12, 24- and 36-month post procedure

OSB Lead-LifeStent SOLO Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
report 02/13/2012 02/08/2012 On Time
two year report 02/13/2013 02/13/2013 On Time
three year report 02/13/2014 02/14/2014 Overdue/Received
four year report 02/13/2015 02/18/2015 Overdue/Received
five year report 02/13/2016 02/16/2016 Overdue/Received
six year report 02/13/2017    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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