PMA P050052S162

Device: RADIESSE® Injectable Implant
Applicant: Merz North America, Inc.
PMA number: P050052
Supplement: S162
Product code: LMH
Decision date: 2026-03-31
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for expanding the indications of Radiesse Injectable Implant diluted 1:2 with 0.9% sterile saline solution for subdermal implantation for the correction of décolleté wrinkles in patients 22 years of age and older.

Current openFDA PMA Record#

Device: RADIESSE® Injectable Implant
Applicant: Merz North America, Inc.
PMA number: P050052
Supplement: S162
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-03-31
Decision code: APPR
Date received: 2024-05-22
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for expanding the indications of Radiesse Injectable Implant diluted 1:2 with 0.9% sterile saline solution for subdermal implantation for the correction of décolleté wrinkles in patients 22 years of age and older.