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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-Long Term Safety


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General
Application Number P010047 / PAS001
Current Plan Approved 03/16/2015
Study Name OSB Lead-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



OSB Lead-Long Term Safety Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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

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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