Post-Approval Studies (PAS)

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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CyPass Micro Stent New Enrollment PAS

General
Study Status	Progress Adequate
Application Number	P150037 / PAS002
Date Current Protocol Accepted	08/18/2017
Study Name	CyPass Micro Stent New Enrollment PAS
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	Objective Performance Criterion
Analysis Type	Analytical
Study Population	Adult: >21

CyPass Micro Stent New Enrollment PAS Schedule

Report Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
six month report	01/27/2017	01/25/2017	On Time
one year report	07/29/2017	07/25/2017	On Time
18 month report	01/27/2018	01/26/2018	On Time
two year report	07/29/2018	07/25/2018	On Time
three year report	07/29/2019
four year report	07/28/2020
five year report	07/28/2021
six year report	07/28/2022
final report	07/20/2023

Contact Us

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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

Related Links

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order" - June 15, 2009
• PAS Database Background
• PAS FAQs