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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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Application Number P070013 / PAS001
Current Plan Approved 09/15/2008
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is an open-label, multi-center, prospective study designed to assess the safety of EVOLENCE in subjects with Fitzpatrick skin types IV, V, and VI seeking correction of facial wrinkles.
Study Population Description The study population is as per device indication. The device is indicated for [add here] The Study Population includes patients 18 years or older with Fitzpatrick skin types IV, V and VI who have clinical evidence of moderate to deep bilateral wrinkles in the nasolabial area corresponding to a rating of at least 2 on the validated MFWS. Indication: injection into the mid to deep dermis for the correction of moderate to deep facial wrinkles and folds;
Sample Size 165 patients, 10 sites
Data Collection The effectiveness endpoint is the change in Modified Fitzpatrick Wrinkle Scale at six months. The safety endpoint is a composite measure of keloid formation and pigmentation change at 6 months post optimal cosmetic results visit.
Follow-up Visits and Length of Follow-up The study required 6 month follow-up. Data collection at office visits included adverse events, Modified Fitzpatrick Wrinkle Scale. Visits were scheduled at 4 days, 1, 3, 6 months after the last injection.
Final Study Results
Interim Safety Information There were three serious adverse events were reported during the study. This included one hospitalization due to bladder failure, one uterine fibroid diagnosis and hysterectomy, and one lung cancer. These events are considered not related to the device or procedure.


Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 12/26/2008 12/23/2008 On Time
1 year report 06/27/2009 06/18/2009 On Time
18 month report 12/26/2009 12/28/2009 Overdue/Received
Final Report 06/27/2010 06/28/2010 Overdue/Received

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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