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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SPYRAL HTN-OFF MED and HTN-ON MED Cont f/u studies


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General
Study Status Ongoing
Application Number /
Requirement Number		 P220026 / PAS001
Date Original Protocol Accepted 11/17/2023
Date Current Protocol Accepted  
Study Name SPYRAL HTN-OFF MED and HTN-ON MED Cont f/u studies
Device Name Symplicity Spyral™ Renal Denervation System
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Population Device only
Sample Size up tp 200
Key Study Endpoints • Office and ambulatory blood pressure
• Renal imaging
• Adverse events
Follow-up Visits and Length of Follow-up 5 years post procedure


SPYRAL HTN-OFF MED and HTN-ON MED Cont f/u studies Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 01/26/2024 01/26/2024 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

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