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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Continued Follow-up of Premarket Cohort

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Study Status Progress Adequate
Application Number P100018 / PAS001
Date Current Protocol Accepted 06/27/2011
Study Name OSB Lead-Continued Follow-up of Premarket Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Single arm prospective cohort
Study Population Description Pipeline Embolic Device pivotal study cohort and the (device and control continued access cohort follow up. These were patients group) with wide-necked intracranial aneurysms in the internal

carotid artery from the petrous to the superior hypophyseal segments.

Sample Size (no. 134 subjects, 2-subgroup analyses by aneurysm location

study sites and and by hypertension status


Data Collection Ipsilateral stroke or neurovascular death Secondary: complete occlusion of treated aneurysm,

stenosis of the parent artery in PED, and device-related adverse events.

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

OSB Lead-Continued Follow-up of Premarket Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/05/2011 10/05/2011 On Time
one year report 04/05/2012 05/23/2012 Overdue/Received
18 month report 10/04/2012 10/04/2012 On Time
two year report 04/05/2013 04/23/2013 Overdue/Received
three year report 04/05/2014 04/07/2014 Overdue/Received
four year report 04/05/2015 04/06/2015 Overdue/Received
60 month report (5 year) 05/23/2016 05/23/2016 On Time
Final Report 12/22/2016 12/23/2016 Overdue/Received
Amended 5 year report 12/23/2016 12/23/2016 On Time

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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