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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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(US GPS) New Enrollment Registry Study


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General
Study Status Protocol Pending
Application Number /
Requirement Number
P220023 / PAS002
Study Name (US GPS) New Enrollment Registry Study
Device Name Paradise® Ultrasound Renal Denervation System
General Study Protocol Parameters
Study Population Adult: >21


(US GPS) New Enrollment Registry Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/07/2024    
1 year report 11/06/2024    
2 year report 11/06/2025    
3 year report 11/06/2026    


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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