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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Natrelle and 410 Combined Cohort

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Study Status Progress Adequate
Application Number P040046 / PAS003
Date Current Protocol Accepted 08/25/2016
Study Name Natrelle and 410 Combined Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

Natrelle and 410 Combined Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/21/2013 08/20/2013 On Time
one year report 02/20/2014 02/18/2014 On Time
18 month report 08/27/2014 08/27/2014 On Time
two year report 02/20/2015 02/20/2015 On Time
6 month report (new study) 02/03/2016 02/03/2016 On Time
1 year report 08/03/2016 08/02/2016 On Time
18 month report 02/03/2017 02/03/2017 On Time
2 year report 08/03/2017 08/02/2017 On Time
3 year report 08/03/2018 08/03/2018 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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