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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-Lead Extraction Study

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Study Status Completed
Application Number P100026 / PAS004
Date Current Protocol Accepted 02/18/2014
Study Name OSB Lead-Lead Extraction Study
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an open-label prospective observational study of patients treated with the RNS System. Patients are from both continued follow-up of premarket cohorts and new enrollment.
Study Population Description All patients implanted with the RNS Neurostimulator and/or Lead(s), including patients in the LTT study and the RNS System PAS2 study, as well as non-study patients whose product data are monitoring systems that consent and have surgical procedures for explant/removal, reimplantation, or revision of the Neurostimulator and Lead(s).
Sample Size A minimum of 20 procedures to remove a Lead must be collected.
Data Collection The incidence and number of adverse events related to surgical

procedures associated with implant, explant/removal, reimplantation, and revision of the Neurostimulator and Lead(s)

Two groups of adverse events will be presented: (1) adverse events that lead to a surgical procedure, and (2) adverse events that occur as a consequence of a surgical procedure (i.e. complication). Within each of the 2 adverse event groups, the incidence and number of events will be presented for 3 categories:

¿ Serious adverse events

¿ Serious device-related adverse events

¿ Non-serious adverse

Follow-up Visits and Length of Follow-up N/A and N/A

OSB Lead-Lead Extraction Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 05/15/2014 05/13/2014 On Time
one year report 11/14/2014 11/13/2014 On Time
18 month report 05/15/2015 05/14/2015 On Time
two year report 11/14/2015 11/02/2015 On Time
three year report 11/13/2016 11/07/2016 On Time
Final Report 11/13/2017 10/23/2017 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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