• 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-Deep Hyperthermia and Radiation

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Application Number H090002 / PAS001
Current Plan Approved 11/13/2013
Study Name OSB Lead-Deep Hyperthermia and Radiation
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Interventional; Open Label; Uncontrolled; Registry
Study Population Description Females that are 21 and older that are ineligible to undergo chemotherapy.
Sample Size All patients treated with the BSD-2000 over the 3-year enrollment period
Data Collection 1st endpoint ¿ complete tumor response (CR); 2nd endpoints ¿ safety (i.e. adverse events and toxicity) and survival determined from day 0
Follow-up Visits and Length of Follow-up Up to 36 months after enrollment and expect follow-up completion to be done 72 months following study.

Follow-up exams will be performed at 3, 6, 12, 18, 24, and 36 month intervals.

OSB Lead-Deep Hyperthermia and Radiation Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 05/18/2012 05/15/2012 On Time
18 month report 05/18/2013 05/15/2013 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

Phone: (301) 796-6134
Fax: (301) 847-8140

Related Links