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

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Enhanced Surveillance Study

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Study Status Progress Adequate
Application Number H090002 / PAS002
Date Current Protocol Accepted 11/13/2013
Study Name 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.

Enhanced Surveillance Study Schedule

Report Schedule
Date Due
FDA Receipt
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 03/31/2017 Overdue/Received
four year report 04/20/2018 06/25/2018 Overdue/Received
five year report 11/13/2018 11/13/2018 On Time
interim progress report 06/04/2019 06/04/2019 On Time
six year report 11/13/2019 10/31/2019 On Time
interim progress report 05/12/2020 05/12/2020 On Time
seven year report 11/13/2020    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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