Post-Approval Studies (PAS) Database

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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Post ExAblate Pregnancy Outcomes Registry

General
Study Status	Delayed
Application Number / Requirement Number	P040003 S015/ PAS001
Date Original Protocol Accepted	08/31/2015
Date Current Protocol Accepted	07/23/2025
Study Name	Post ExAblate Pregnancy Outcomes Registry
Device Name	EXABLATE
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	Sponsor Registry
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	This is an observational [single cohort] global Post-ExAblate Pregnancy Outcome Registry-based Study. The objective is to collect safety information regarding patient pregnancy/outcomes following treatment of their symptomatic fibroid(s) with the ExAblate MR guided focused ultrasound system. All adverse events that are possibly related to pregnancies and pregnancy outcomes, including post-partum complications for both mother and infant, will be collected in consenting patients.
Study Population	All consented patients from participating sites who receive an ExAblate procedure or have previously undergone an ExAblate procedure for symptomatic uterine fibroids will be recruited for this registry. There is no control group.
Sample Size	The registry is open to all who would consent at participating sites, and will be open for enrollment for two years. The study aims to enroll up to 198 patients in total. A minimum of ten sites from around the world will participate, including a minimum of six sites from the U.S.
Key Study Endpoints	Main safety endpoint: Adverse events related to pregnancies, including but not limited to pregnancy outcome, and post-partum complications for the mother and infant. The nature of each adverse event, date and time (when appropriate) of onset, outcome, frequency, maximum intensity, action taken, expectedness, and causal relationship will be recorded.
Follow-up Visits and Length of Follow-up	Up to two years after ExAblate treatment, or until pregnancy completion. Sites should contact the subject 2 times a year (approximately every 6 months) for 2 years after the ExAblate procedure.

Post ExAblate Pregnancy Outcomes Registry Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	02/29/2016	03/07/2016	Overdue/Received
1 year report	08/30/2016	08/25/2016	On Time
18 month report	02/28/2017	03/03/2017	Overdue/Received
2 year report	08/30/2017	09/08/2017	Overdue/Received
3 year report	08/30/2018	09/06/2018	Overdue/Received
4 year report	08/30/2019	09/23/2019	Overdue/Received
5 year report	08/29/2020	09/18/2020	Overdue/Received
6 year report	08/30/2021	09/15/2021	Overdue/Received
7 year report	08/30/2022	09/23/2022	Overdue/Received
8 year report	08/30/2023	08/18/2023	On Time
9 year report	08/30/2024	07/25/2024	On Time
final report	08/30/2025	08/28/2025	On Time

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background