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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-Enhanced Surveillance Study


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General
Application Number H090002 / PAS002
Current Plan Approved 11/13/2013
Study Name OSB Lead-Enhanced Surveillance Study
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Enhanced Surveillance Study designed to evaluate the safety of BSD-2000 Hyperthermia System. Sites will be contacted on a quarterly basis.

Study Population Description Patients with cervical cancer treated with BSD-2000. Patients who

have had or not had prior irradiation of the treatment site also will be included. Patients who have had chemotherapy administered also will be included.

Sample Size No specified sample size or number of clinical sites.
Data Collection Evaluation of complaints involving injury and adverse events,

including acute and late toxicity associated with hyperthermia and radiotherapy treatment.

Follow-up Visits and Length of Follow-up Up to 3 years.

There are no scheduled follow-up visits for the patients. Adverse

events will be captured using the Case Report Forms. The sites will be contacted quarterly for data.



OSB Lead-Enhanced Surveillance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/13/2014 05/14/2014 Overdue/Received
one year report 11/13/2014 11/26/2014 Overdue/Received
rqst suspend rprting-18 mon report 09/25/2015 09/25/2015 On Time
two year report 11/13/2015   Overdue


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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