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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Sort By Application Number Application
Sort By Application Number -- Descending
Sort By Manufacturer Applicant Sort By Manufacturer -- Descending
   Sort By Device Name Device
Sort By Device Name -- Descending
Sort By Medical Specialty Medical
Sort By Medical Specialty -- Descending
Sort By Date Order Date PMA
Sort By Date Order -- Descending
Study Status
P220029 Urotronic, Inc Optilume™ BPH Catheter System Gastroenterology/
06/30/2023 PEAK PAS Ongoing
PINNACLE Study Study Pending

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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