f Post-Approval Studies (PAS) Database
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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 New Enrollment (NESTed-PAS)


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General
Study Status Redesigned/Replaced Study
Application Number /
Requirement Number		 P130013 / PAS002
Date Original Protocol Accepted 11/21/2016
Date Current Protocol Accepted 11/30/2016
Study Name WATCHMAN New Enrollment (NESTed-PAS)
Device Name WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
General Study Protocol Parameters
Study Population Adult: >21


WATCHMAN New Enrollment (NESTed-PAS) Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
4 month report 07/12/2015 08/07/2015 Overdue/Received
one year report 03/12/2016 02/08/2016 On Time
16 month report 07/11/2016 03/11/2016 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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