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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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Application Number P070014 / PAS001
Current Plan Approved 07/11/2014
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a single-arm, non-randomized, prospective, multi-center international study in subjects (>=22 years of age) with TransAtlantic Inter-Society Consensus A, B and C lesion(s) in the infra-inguinal segment (SFA and/or Popliteal arteries). Subjects will be treated with PTA followed by the LifeStent Self-Expanding Stent System (FlexStar / FlexStar XL). The primary objectives of this investigation are to provide confirmatory evidence of safety and effectiveness of the LifeStent Self-Expanding Stent System in patients with de novo and restenotic (non-stented) lesion(s) in the infra-inguinal segment (SFA and/or Popliteal arteries). A secondary objective of this investigation is to continue to evaluate the clinical utility of the LifeStent Self-Expanding Stent System.
Study Population Description This device is indicated for improvement of luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 160 mm in length in the native superficial femoral artery and proximal popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.
Sample Size 170 patients, 20 sites
Data Collection The primary safety endpoint is freedom from death at 12-months post-procedure. The primary effectiveness is freedom from procedural device malfunction.
Follow-up Visits and Length of Follow-up Subjects will undergo a clinical evaluation at baseline (prior to study procedure), prior to hospital discharge, 30 days post-procedure, 12, 24 and 36 months post-procedure.
Final Study Results
Interim Safety Information The sponsor has yet to enroll patients in this study.


Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 08/14/2009 08/13/2009 On Time
1 year report 02/13/2010 02/12/2010 On Time
18 month report 08/14/2010 08/13/2010 On Time
2 year report 02/13/2011 02/11/2011 On Time
3 year report 02/13/2012 02/08/2012 On Time
4 year report 02/13/2013 02/13/2013 On Time
5 year report 02/12/2014 02/14/2014 Overdue/Received
6 year report 02/12/2015 02/18/2015 Overdue/Received
7 year report 02/13/2016 02/16/2016 Overdue/Received
8 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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