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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Long-Term Surveillance of MedStream

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Study Status Other
Application Number P890055 S026/ PAS001
Date Current Protocol Accepted 03/15/2011
Study Name Long-Term Surveillance of MedStream
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, single arm, multi-center study with consecutive enrollment.

The null hypothesis for this study states that subjects implanted with the MedStream system will have a MedStream system-related AE rate that is greater than or equal to an Objective Performance Criterion (OPC).

Study Population Description The study population included patients presenting for de novo implant or replacement of an implantable programmable infusion pump for intrathecal therapy.
Sample Size Subjects will be enrolled in the study to account for loss to follow-up and for ineligibility to achieve evaluable subjects. The study will be conducted at a minimum and a maximum number of centers in the U.S. with prior IRB approval for this study.
Data Collection

The primary endpoint is based on Clinical Events Committee determination of relationship.

Follow-up Visits and Length of Follow-up All subjects are to be followed for a few months and are required to have a minimum of office or hospital-based visits every few months as long as he/she is enrolled in this study. These visits will be documented in the study records, and data will be collected on the Subject's current intrathecal drug therapy. Follow-up visits will be scheduled as deemed necessary by the treating Clinician.

Long-Term Surveillance of MedStream Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/17/2011 06/16/2011 On Time
one year report 12/17/2011 12/15/2011 On Time
18 month report 06/16/2012 06/15/2012 On Time
two year report 12/16/2012 12/17/2012 Overdue/Received
30 month report 06/16/2013 06/20/2013 Overdue/Received
three year report 12/16/2013 12/16/2013 On Time
39 month report 05/14/2014 05/14/2014 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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