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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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Sculptra HF PAS


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P030050 S034/ PAS001
Date Original Protocol Accepted 01/21/2022
Date Current Protocol Accepted  
Study Name Sculptra HF PAS
Device Name Sculptra and Sculptra Aesthetic
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Objective: To validate that Sculptra training material reduces use-related risk to an acceptable level.
Design: Test participants will be provided with Sculptra training materials and asked to review the materials. Following training, the participant will exit the study room and a training decay period of one hour will commence. During the decay, the participant will be asked to complete distractor tasks (e.g., complete surveys, puzzles, etc., that are unrelated to Sculptra). Test sessions will be conducted at a research facility in a room set up to simulate a room in a medical spa and will include a table with supplies for reconstituting and a separate area with patient bed where the participant will administer injections to a simulated skin pad placed on the bed. Study participants may sit or stand, based on preference. During a test session, participants will be asked to complete one simulated use scenario. In the scenario, the participant will reconstitute Sculptra then inject prepared Sculptra into an injection pad. Critical tasks related to reconstitution and injection will be evaluated.
Study Population Device group: Licensed aesthetic injector (RN/NP/PA or MD/DO) experienced with injecting facial fillers.
Comparator group: None.
Sample Size 15
Key Study Endpoints Evaluation of critical tasks related to correctly reconstituting and injecting Sculptra.
Follow-up Visits and Length of Follow-up None


Sculptra HF PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 05/18/2022 05/18/2022 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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