PMA P050052S174

Device: RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication
Applicant: Merz North America, Inc.
PMA number: P050052
Supplement: S174
Product code: LMH
Decision date: 2026-01-13
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: adding a new surface area analyzer in quality control testing of calcium hydroxyapatite (CaHA) particles

Current openFDA PMA Record#

Device: RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication
Applicant: Merz North America, Inc.
PMA number: P050052
Supplement: S174
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-01-13
Decision code: OK30
Date received: 2025-12-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adding a new surface area analyzer in quality control testing of calcium hydroxyapatite (CaHA) particles