• 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...


Long Term Safety

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Progress Adequate
Application Number P010047 / PAS001
Date Current Protocol Accepted 03/16/2015
Study Name Long Term Safety
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, non-randomized, controlled observational study with a ProGel PALS group and a comparison group of standard-of-care, multi-center cohort study.

Study Population Description Newly enrolled consecutive patients post-approval study population
Sample Size 400 evaluable subjects (267 ProGEL Sealant + 133 Control) at up to 30 U.S. sites.

Data Collection Primary Endpoints:

The study will include evaluation of twelve safety endpoints (i.e. specified AE). These include:

1. Pneumothorax

2. Air leak, persistent

3. Air leak, late onset

4. Residual pleural space

5. Acute respiratory distress syndrome (ARDS)

6. Post-surgical renal abnormalities

7. Myocardial infarction

8. Atrial arrhythmia requiring treatment

9. Ventricular arrhythmia requiring treatment

10. Cardiac arrest (resuscitated)

11. Death (all causes)

12. Hospital readmission (related to pulmonary surgery)

Follow-up Visits and Length of Follow-up 5 years: 30-day and 90-day follow-up visits are scheduled for study assessments

Long Term Safety Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 01/14/2011 01/14/2011 On Time
18 month report 07/15/2011 07/14/2011 On Time
2 year report 01/14/2012 01/13/2012 On Time
rqst to change report dates 10/16/2012 10/16/2012 On Time
3 year report 01/13/2013 01/14/2013 Overdue/Received
4 year report 01/13/2014 01/13/2014 On Time
5 year report 01/13/2015 01/12/2015 On Time
6 year report 01/13/2016 01/12/2016 On Time
Final Report 04/01/2016 04/01/2016 On Time

Contact Us

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

Related Links