f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Working Standard for Biomatrix


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General
Study Status Completed
Application Number /
Requirement Number		 P040013 S009/ PAS001
Date Original Protocol Accepted 08/25/2008
Date Current Protocol Accepted 08/25/2008
Study Name Working Standard for Biomatrix
Device Name GEM 21S (GROWTH ENHANCED MATRIX)
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source Other Data Source
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Development of a new working standard for use in analytical testing of the rhPDGF-BB component of GEM 21S Growth-factor Enhanced Matrix.
Study Population N/A
Sample Size N/A
Key Study Endpoints N/A
Follow-up Visits and Length of Follow-up N/A
Interim or Final Data Summary
Interim Results Study completed, see final results
Actual Number of Patients Enrolled N/A
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Final Safety Findings The proposed specification is acceptable given the constraints of the assay and equipment precision.
Study Strengths & Weaknesses N/A
Recommendations for Labeling Changes N/A


Working Standard for Biomatrix Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final Report 10/03/2008 09/08/2008 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

Additional Resources

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