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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-QP ExCELS Sentus QP Ext CRT w/ Quad LV


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General
Study Status Study Pending
Application Number P070008 S079/ PAS001
Study Name ODE Lead-QP ExCELS Sentus QP Ext CRT w/ Quad LV
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Confirm long-term safety of the Biotronik Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 5 years post-implant.
Study Population Description CRT-eligible Heart Failure patients
Sample Size Postmarket Sample Size Required: 979

Postmarket Sample Size Required including attrition = 1754

Data Collection Primary Endpoint: The purpose is to evaluate the long-term Sentus related complication-free rate through 5 years post-implant.
Follow-up Visits and Length of Follow-up 5 years


ODE Lead-QP ExCELS Sentus QP Ext CRT w/ Quad LV Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/02/2017 11/02/2017 On Time
one year report 05/04/2018    
two year report 05/04/2019    
three year report 05/03/2020    
four year report 05/03/2021    
five year report 05/03/2022    


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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