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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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PAS of HeartLight Endoscopic Ablation Sys


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General
Study Status Progress Inadequate
Application Number P150026 / PAS001
Study Name PAS of HeartLight Endoscopic Ablation Sys
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


PAS of HeartLight Endoscopic Ablation Sys Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/30/2016 09/27/2016 On Time
one year report 04/01/2017 03/31/2017 On Time
18 month report 09/30/2017 09/29/2017 On Time
two year report 04/01/2018 03/30/2018 On Time
30 month report 10/30/2018 10/30/2018 On Time
three year report 04/01/2019    
four year report 03/31/2020    
five year report 03/31/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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