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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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ODE Lead-Post-Approval Study


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General
Study Status Protocol Pending
Application Number P140032 / PAS001
Study Name ODE Lead-Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The ISR PAS is a prospective, open-label, observational, multi-center study. 50 newly implanted US subjects will be followed for five years.



Primary Objectives:

To estimate the freedom from catheter-related complications through 5 years post-implant.

To estimate the freedom from ISR pump-related complications through 5 years post implant.

Ancillary Objective

The ancillary objective is descriptive in nature and is intended to gain additional information about the performance of the ISR pump: Plot pump fluid delivery accuracy ratio over time and compare to the intended market-release labeling describing flow rate accuracy performance expected versus refill number.



Study Population Description Patients intended to be implanted with an ISR are eligible for enrollment into the ISR PAS.

Sample Size 50
Data Collection The endpoint of this objective is catheter-related complications.

If an adverse event indicates that there is unknown relatedness to the catheter, and the event is classified as a complication, it will be counted as a catheter-related complication. Additionally, in the event of a pneumothorax being adjudicated by the CEC as procedure-related, and the event is classified as a complication, it will count toward the primary objective. A patency test for suspected occlusion or elective removal of the implanted system will not be considered a complication.



The endpoint of this objective is pump complications.

Pump-related complications will be defined as any adverse device event that results in death, involves any termination of significant device function, or requires an invasive intervention. A patency test for suspected occlusion, pump refill, elective change-out of the pump during a catheter replacement/revision, or elective removal of implanted system will not be considered a complication.



Plot pump fluid delivery accuracy ratio over time and compare to the intended market-release labeling describing flow rate accuracy performance expected versus refill number.





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


ODE Lead-Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/22/2018    
one year report 12/22/2018    
18 month report 06/22/2019    
two year report 12/22/2019    
three year report 12/21/2020    
four year report 12/21/2021    


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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