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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Essure/post-NovaSure PAS


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General
Application Number P020014 S017/ PAS001
Current Plan Approved 09/29/2016
Study Name OSB Lead-Essure/post-NovaSure PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Single-arm multi-center prospective observational study
Study Population Description Women aged 21-50 with Essure microinserts properly placed

(confirmatory HSG) seeking treatment for menorrhagia.

Sample Size A minimum of 220 female subjects relying on Essure micro- inserts seeking treatment for menorrhagia (i.e. NovaSure) at up to 15 US sites.
Data Collection Occurrence of confirmed pregnancy at 1 year and 3 years among subjects relying on Essure micro-inserts for permanent birth control when NovaSure is performed
Follow-up Visits and Length of Follow-up 3 years

One week post Novasure procedure, then one and three year Post-EA Contraception Phone Call



OSB Lead-Essure/post-NovaSure PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/24/2012 12/14/2012 Overdue/Received
one year report 02/23/2013 03/08/2013 Overdue/Received
18 month report 08/24/2013 09/12/2013 Overdue/Received
two year report 03/21/2014 03/24/2014 Overdue/Received
three year report 02/23/2015 02/27/2015 Overdue/Received
42 month report due 08/23/2015 08/19/2015 On Time
four year report 02/23/2016 02/22/2016 On Time
five year report 02/22/2017    


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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