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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LVIS X PAS


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General
Study Status Other
Application Number /
Requirement Number		 P170013 S005/ PAS001
Date Original Protocol Accepted 06/28/2022
Date Current Protocol Accepted 06/28/2022
Study Name LVIS X PAS
Device Name Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
General Study Protocol Parameters




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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