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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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WATCHMAN FLX LAA Closure Device w/Delivery RW Use

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Study Status Study Pending
Application Number P130013 S035/ PAS002
Date Current Protocol Accepted  
Study Name WATCHMAN FLX LAA Closure Device w/Delivery RW Use
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Comprehensive/Linked/RegistryBased Surveillance
Study Population Description Patients with attempted implant of the WATCHMAN device enrolled at sites participating in the LAAO egistry.
Sample Size All consecutive patients treated within the first 2 years that are entered into the LAAO Registry.
Data Collection The surveillance will be carried out to characterize clinical outcomes (including: implant success rate, procedural safety, effective closure of the orifice of the left atrial appendage, and stroke [including ischemic or hemorrhagic] through one- year post-implant] and longer term identified occurrence of all stroke (including ischemic or hemorrhagic) and to assess the real-world use of the commercial WATCHMAN FLX LAA Closure Device with Delivery System.
Follow-up Visits and Length of Follow-up Patients will be followed through five years post implant.

WATCHMAN FLX LAA Closure Device w/Delivery RW Use Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 01/19/2021 01/21/2021 Overdue/Received
one year report 07/21/2021 07/21/2021 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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