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

Learn more...


             

OSB Lead-Lap-Band Long Term


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Revised/Replaced Study
Application Number P000008 / PAS001
Date Current Protocol Accepted 06/05/2001
Study Name OSB Lead-Lap-Band Long Term
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 This is a prospective cohort, which involved continued follow-up of subjects from the premarket studies, from several different sites. Both prospective and retrospective collection of data was allowed and encouraged.
Study Population Description Study Population: Patients included in the pre-market study. Indication: The LAGB is intended for use in weight reduction for morbidly obese adult patients with a Body Mass Index (BMI) of at least 40 kg/m2, a BMI of at least 35 kg/m2 with at least one co-morbid condition, or those who are 100 lbs. or more above their ideal body weight and who have failed at more conservative weight reducing alternatives.
Sample Size 300 patients, 15 sites
Data Collection Safety endpoints included percent of excess weight loss, adverse events, and explantation of the device.
Follow-up Visits and Length of Follow-up Patients who had completed three years of follow-up in the premarket studies were to be followed for an additional two years.


OSB Lead-Lap-Band Long Term Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
PAS status report 10/15/2007 10/15/2007 On Time
Yearly Report 07/05/2008 07/31/2008 Overdue/Received
Annual report 08/28/2009 08/28/2009 On Time
PAS Annual Report 08/28/2010 09/03/2010 Overdue/Received
report 07/06/2011 07/06/2011 On Time


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

-
-