Post-Approval Studies (PAS) Database

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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Safety Study to Assess Radiographic Imaging

General
Study Status	Study Pending
Application Number / Requirement Number	P050052 S162/ PAS001
Date Original Protocol Accepted	03/31/2026
Date Current Protocol Accepted
Study Name	Safety Study to Assess Radiographic Imaging
Device Name	RADIESSE® Injectable Implant
Clinical Trial Number(s)	NCT05163353
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	Sponsor Registry
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	To determine if treatment with Radiesse dilute in the décolleté interferes with radiographic imaging of the breast tissue and to assess the safety of Radiesse dilute in the décolleté. Participants will receive three treatments spaced six weeks apart (Week 1, Week 7, and Week 13), with each consisting of injection of 1.5 mL Radiesse diluted 1:2 with sterile saline into the décolleté Imaging will be performed at baseline and 1 month after the third administration.
Study Population	Female participants between the ages of 40 and 65
Sample Size	30
Key Study Endpoints	Any interference of Radiesse dilute in either breast observed in breast ultrasound or mammogram images at Week 17, as assessed by an adjudication committee composed of board-certified radiologists. Occurrence of adverse events (AEs) related to treatment with Radiesse dilute, as reported by the treating investigator throughout the study.
Follow-up Visits and Length of Follow-up	Total participation 60 weeks

Safety Study to Assess Radiographic Imaging Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	09/29/2026
1 year report	03/31/2027
2 year report	03/30/2028
3 year report	03/30/2029
4 year report	03/30/2030

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background