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Radiesse Injectable Implant

FDA PMA

Class III (US FDA PMA)

PMA P050037

by Merz North America, Inc.

Identity

Trade Name
RADIESSE 1.3CC AND 0.3CC FDA PMA
Generic Name
Implant, dermal, for aesthetic use FDA PMA

Identifiers

PMA Number
P050037 FDA PMA
FDA Product Code
LMH FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APPR Approved FDA PMA

Radiesse Injectable Implant is a dermal implant indicated for subdermal implantation for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. It is supplied as Radiesse 1.3cc and 0.3cc formulations.

The device is manufactured by Merz North America, Inc. in Franksville, Wisconsin. It received FDA PMA approval (P050037) on December 22, 2006, following submission on September 29, 2005. The product is classified as a Class III device under product code LMH and is intended for aesthetic use in dermal implantation.

Frequently asked questions

What is the Radiesse Injectable Implant used for?

The Radiesse Injectable Implant is indicated for subdermal implantation to restore and/or correct the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus, as stated in the approval documentation.

Who manufactures the Radiesse Injectable Implant and where is it made?

The Radiesse Injectable Implant is manufactured by Merz North America, Inc., located at 4133 Ct.ney Rd., Suite 10, Franksville, WI 53126.

What regulatory authorization does the Radiesse Injectable Implant have?

The Radiesse Injectable Implant has FDA PMA approval under application number P050037, with approval granted on December 22, 2006.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Merz Aesthetics: Radiesse, Radiesse® Filler - Volumen, Kontur & Kollagen Boost¹˒³˒⁵⁻¹² | Merz ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Merz North America, Inc.

Sources (1)

  • FDA PMA P050037 24 fields · synced Sep 18, 2026