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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-NeoMend ProGel Pleural Air Leak Sealant

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Application Number P010047 S010/ PAS001
Current Plan Approved 03/16/2015
Study Name OSB Lead-NeoMend ProGel Pleural Air Leak Sealant
General Study Protocol Parameters
Study Design Case Control Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, observational cohort study with a ProGEL Sealant group and a comparison group of standard-of-care.
Study Population Description 267 ProGEL Sealant + 133 Comparison Group. Subjects in the comparison group follow the current standard of care to treat IOAL after lung resection is defined by techniques involve suturing, stapling, and cauterization of the lung parenchyma where the leak is detected
Sample Size 267 ProGEL Sealant + 133 Control
Data Collection Study Endpoints 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 90 days

OSB Lead-NeoMend ProGel Pleural Air Leak Sealant Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/20/2012 08/22/2012 Overdue/Received
one year report 01/13/2013 01/14/2013 Overdue/Received
two year report 01/13/2014 01/13/2014 On Time
three year report 01/13/2015 01/12/2015 On Time
four 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

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

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