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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-PROMUS Element Plus US PAS


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General
Application Number P110010 S001/ PAS001
Current Plan Approved 08/24/2012
Study Name OSB Lead-PROMUS Element Plus US PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, open-label, multi-center registry study
Study Population Description PLATINUM-like patients, including at least 200 patients treated with PROMUS Element Plus long lesion stents 32/38 mm lengths (2.50-4.0mm diameters).
Sample Size 2,689 consecutive, consented patients from up to 65 sites in order to attain 906 PLATINUM like patients from the US PAS (33.7% of the enrolled patients)
Data Collection Primary: Cardiac death or myocardial infarction rate through 12 months post stent implantation among all PLATINUM-like patients

Secondary: Stent thrombosis rate, longitudinal stent deformation, and PROMUS Element plus related MACE, cardiac death/MI, TVF, TVR, cardiac death, and MI.

Follow-up Visits and Length of Follow-up 5 years

30- days, 180-days, and annually through 5 years post intervention



OSB Lead-PROMUS Element Plus US PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 08/31/2012 09/20/2012 Overdue/Received
6 month report 11/30/2012 11/16/2012 On Time
9 month report 06/01/2013 06/03/2013 Overdue/Received
one year report 06/01/2013 06/03/2013 Overdue/Received
18 month report 11/30/2013 11/20/2013 On Time
two year report 06/01/2014 05/30/2014 On Time
30 month report 11/21/2014 11/21/2014 On Time
three year report 11/21/2015 11/25/2015 Overdue/Received
unscheduled report 01/27/2016 01/27/2016 On Time
four year report 11/21/2016   Overdue
five year report 11/21/2017    


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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