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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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Working Standard for Biomatrix

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Application Number P040013 S009/ PAS001
Current Plan Approved 08/25/2008
Study Name Working Standard for Biomatrix
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 Design Description 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 Description N/A
Sample Size N/A
Data Collection N/A
Follow-up Visits and Length of Follow-up N/A
Final Study Results
Interim Safety Information Study completed, see final results
Number of Patients N/A
Number of Sites N/A
Follow-up Rate N/A
Safety Findings The proposed specification is acceptable given the constraints of the assay and equipment precision.
Strengths & Weaknesses N/A
Label Changes N/A

Working Standard for Biomatrix Schedule

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