• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

OSB Lead-NovaSure PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Application Number P010013 S041/ PAS001
Current Plan Approved 06/15/2015
Study Name OSB Lead-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 Prospective, single-arm, multi-center study
Study Population Description Premenopausal women greater than or equal to 18 years old with menorrhagia due to benign causes for whom childbearing is complete and have received an Essure Permanent Birth Control System
Sample Size Up to 21 sites, 318 patients
Data Collection 1. Primary Endpoint: Removal of an Essure micro-insert with the NovaSure device

2. Secondary Endpoints:

2.1. AEs during and/or immediately following the NovaSure procedure;

2.2. AEs up to 1 month after the NovaSure procedure

Follow-up Visits and Length of Follow-up 1 Month

1 Follow-up assessment



OSB Lead-NovaSure PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/02/2013 08/02/2013 On Time
one year report 02/01/2014 02/03/2014 Overdue/Received
18 month report 08/02/2014 07/31/2014 On Time
two year report 02/01/2015 01/30/2015 On Time
30 month report 08/01/2015 07/31/2015 On Time
three year report 02/01/2016 02/01/2016 On Time
42 month report 08/01/2016 07/29/2016 On Time
four year report 01/31/2017    
54 month report 08/01/2017    
five year report 01/31/2018    
66 month report 08/01/2018    
6 year report 01/31/2019    


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

Related Links

-
-