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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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NAVIGATE X4 PAS


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General
Study Status Progress Adequate
Application Number P910073 S145/ PAS001
Study Name NAVIGATE X4 PAS
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 B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description Prospective, nonrandomized, multi-center study intended to evaluate long term performance of the RELIANCE 4-FRONT lead.
Study Population Description The device is designed for right started heart applications within the ventricle, atrium and superior vena cava. It is intended for pacing, rate-sensing a delivery of cardioversion and defibrillation shocks when used with a compatible ICD or CRT-D pulse generator.
Sample Size 2080 patients were consented for follow up and will be followed to meet the 1,000 minimum number of patients expected.
Data Collection The lead-related complication-free rate from 1 to 60 months > 92.5%.



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


NAVIGATE X4 PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/22/2018 08/20/2018 On Time
one year report 02/21/2019 02/21/2019 On Time
18 month report 08/22/2019 08/21/2019 On Time
two year report 02/21/2020    
three year report 02/21/2021    
four year report 02/21/2022    


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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