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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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PINNACLE FLX Cont f/u of IDE Cohort


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General
Study Status Progress Adequate
Application Number P130013 S035/ PAS001
Date Current Protocol Accepted  
Study Name PINNACLE FLX Cont f/u of IDE Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow up of the premarket cohort in the prospective, single arm PINNACLE FLX trial. The study objective is to characterize the safety and effectiveness of the WATCHMAN FLX LAA Closure Device with Delivery System through 24 months post-procedure.
Study Population Description The study consists of all IDE patients who are currently enrolled and alive and are eligible for the secondary effectiveness endpoint evaluation. The secondary effectiveness endpoint is defined in the protocol as the occurrence of ischemic stroke or systemic embolism at 24 months from the time of implant.
Sample Size Initial enrollment in the PINNACLE FLX study was 458 subjects (400 in the main cohort and 58 in the roll-in cohort). Of these 458 subjects, 425 subjects are potentially available for 24 month follow up.
Data Collection The occurrence of ischemic stroke or systemic embolism at 24 months from the time of implant.
Follow-up Visits and Length of Follow-up 24 months


PINNACLE FLX Cont f/u of IDE Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/19/2021 01/21/2021 Overdue/Received
one year report 07/21/2021 07/16/2021 On Time
18 month report 01/19/2022    
two year report 07/21/2022    
three year report 07/21/2023    


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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